Quality & Compliance
Direct supplier statement · To Whom It May Concern
PIK PAK Industries — Letter of Compliance for Toolsmith Ltd
Our supplier PIK PAK Industries (Sialkot, Pakistan) issues a signed letter naming Toolsmith Ltd explicitly — our registered office, Companies House number, and VAT number — confirming that ToolSmith Ltd. is "fully authorized to import, distribute, and sell these products within their market". The letter lists these certifications and approvals:
- ISO 9001 — Quality Management System
- ISO 13485 — Quality Management System for Medical Devices
- MDR Compliance for Class I Medical Devices
- EU Authorised Representative (EU REP) — Active and Valid
- REACH Compliance Certificate
Download the supplier letter (PDF)
Read the full letter as text (verbatim transcription)
The letter is signed but undated and carries no reference number; our copy has been on file since May 2026. Spelling and punctuation are as printed. The letterhead telephone numbers and e-mail addresses are omitted here.
Letterhead: PIK PAK Industries, "Gold Standard Tools", "Manufacturers & Exporters of Surgical, Dental, Veterinary, Beauty Instruments & All kinds of Scissors". Factory Add: 48-A Small Industrial Estate Sialkot 51310 - Pakistan. Web: www.pikpak-ind.com
To Whom It May Concern
This letter is to confirm that PIK PAK Industries, located in Sialkot, Pakistan, is a registered manufacturing company engaged in the production of precision instruments, tools, and related industrial products.
We hereby state that our company is fully compliant with international quality and regulatory standards. We hold the following certifications and approvals:
- ISO 9001 – Quality Management System
- ISO 13485 – Quality Management System for Medical Devices
- MDR Compliance for Class I Medical Devices
- EU Authorized Representative (EU REP) – Active and Valid
- REACH Compliance Certificate
We further confirm that we are supplying our products to ToolSmith Ltd., located at 39 Heather Road, Small Heath, Birmingham, UK, B10 9TE, United Kingdom, Company Registration No. 16520777, VAT No. GB497504454. ToolSmith Ltd. is fully authorized to import, distribute, and sell these products within their market.
Should you require any additional documentation, verification, or clarification regarding our compliance status, certifications, or product scope, please feel free to contact us.
Sincerely,
PIK PAK Industries
Haroon Arif.
48A Small Industrial Estate
Sialkot, Pakistan
[e-mail address omitted][Handwritten signature over the stamp "PIK PAK Industries" / "Partner"]
Manufacturer address as printed on each document
PIK PAK Industries' address appears in two forms on these documents: the ISO certificates and PIK PAK's own letterhead give 48-A Small Industrial Estate, Sialkot 51310; the IBC-issued EC REP and REACH certificates give Pakka Peya, Small Industrial Estate, Defence Road, Sialkot 51310. Both forms describe the same PIK PAK Industries site, confirmed by Toolsmith Ltd on 1 October 2026. Each is quoted exactly as printed:
| Document | Address as printed |
|---|---|
| ISO 9001 certificate QMS1224 (Rev. 01) | 48-A, Small Industrial Estate, Sialkot-51310, Pakistan |
| ISO 13485 certificate PK250801003 | 48-A, Small Industrial Estate, Sialkot-51310 Pakistan |
| Supplier letter (letterhead) | Factory Add: 48-A Small Industrial Estate Sialkot 51310 - Pakistan (signature block: 48A Small Industrial Estate, Sialkot, Pakistan) |
| EC REP certificate IBC 02502141A (issued by IBC Sweden) | Pakka Peya, Small Industrial Estate, Defence Road Sialkot – 51310, Pakistan |
| REACH certificate IBC 9251310/9270 (issued by IBC) | Pakka Peya, Small Industrial Estate, Defence Road, Sialkot-51310, Pakistan |
Below are the underpinning individual certificates referenced in the supplier letter.
ISO 13485:2016 — Medical Device Quality Management System
The international standard for organisations involved in any stage of the medical-device life-cycle. Our supplier's ISO 13485 certification was issued by LMS Assessments Limited (UK Companies House registered, IAF and EGAC accredited), and covers the manufacturing of non-active surgical and dental instruments including hammers, scalpels, forceps, retractors, rongeurs, drills, reamers, biopsy instruments, dental probes, mirrors, scalers, articulators, trocars and cannulas.
- Certificate number: PK250801003
- Issued: 01 August 2025
- Date of this certificate: 14 August 2026 (renewed following successful surveillance audit)
- Surveillance audit due / certificate expiry: 31 July 2027
- Recertification due: 31 July 2028
- Issuer: LMS Assessments Limited (IAF + EGAC accredited)
Download ISO 13485 certificate (PDF)
EU MDR Authorised Representative
Under EU Medical Device Regulation 2017/745 (MDR), every non-EU manufacturer placing medical devices on the EU market must appoint an EU-based Authorised Representative. PIK PAK Industries has appointed IBC Sweden (SRN SE-AR-000001625) as its EC Representative: certificate IBC 02502141A, issued 13 February 2026 and valid to 12 February 2027, covering the Class I medical devices listed in its Annex A.
Download MDR EC Rep documentation (PDF)
Annex A - products covered by the EC REP mandate (IBC 02502141A)
Transcribed from Annex A (parts 2/5 to 5/5) of the IBC Sweden certificate of registration. Article numbers are the manufacturer's (PIK PAK Industries) and are reproduced as printed on the certificate. Every line is Medical Devices Classification I.
| Name | Article numbers | MDR class |
|---|---|---|
| Ligature Tying and Tuckers | LR-01 to LR-20 | I |
| Dental Forceps | S2-01 to S2-04, S2-11 to S2-18 | I |
| Mallets/Hammers | S21-1 to S21-4 | I |
| Direct Bond Bracket Holder | ED2-21 to ED2-32 | I |
| Tweezers (Non-Surgical) | D4-01 to D4-05 | I |
| Tooth Extraction Forceps | E1-01 to E1-65 | I |
| Mixing Well | R7-01, S16-11 to S16-17 | I |
| Suture Forceps | S4-401 to S4-447 | I |
| Cement Spatula | R6-4, R6-6, R6-8, Li-64 | I |
| Self-Retaining Retractor (Non-Surgical) | 08-101-50 to 08-230-100 | I |
| Scissors (Non-Surgical) | SS-01 to SS-40 | I |
| Scalpel Handles | S5-01 to S5-07 | I |
| Dental Elevators | E2-01 to E2-09, E2-1 to E2-89, E3-01 to E3-07, E3-11 to E3-17 | I |
| Lip and Cheek Retractor | S6-1 to S6-29 | I |
| Retractors (Non-Surgical) | SR-50 to SR-70 | I |
| Articulators | Li-01 to Li-28 | I |
| Dental Probes (Non-Measuring) | D2-01 to D2-10, D3-01 to D3-07 | I |
| Dental Periotomes | E4-01 to E4-11 | I |
| Periodontal Curettes | P1-01 to P1-08, P1-11 to P1-19, P2-01 to P2-12, P3-01, P3-02 | I |
| Needle Holders | S2-21 to S2-26, S2-31, S2-32, S2-41, S2-42, S2-51 to S2-53, S2-61, S2-62, S2-70 to S2-84 | I |
| Forceps (Non-Surgical) | SF-01 to SF-50 | I |
| Handles | HS-01 to HS-90 | I |
| Endodontic Explorers | ED4-01 to ED4-10 | I |
| Dental Scissors | S3-111 to S3-115, S3-121 to S3-139, S3-151 to S3 157, S3161, S3162, S3-171, S3-172, S3-181, S3-182, S3-191, S3-200, S3-211 to S3-216 | I |
| Dental Scalers | P4-01 to P4-04, P4-11 to P4-15 | I |
| Dental Rongeurs | S17-1 to S17-13 | I |
| Dental Excavators | ED4-11 to ED4-14, R2-17 to R2-24 | I |
| Dental Burnishers | R3-001 to R3-007 | I |
| Chin Retractor | S6-30 | I |
| Clamps (Non-Surgical) | S2-15, S2-16 | I |
| Band Pusher | ED2-10 to ED2-12 | I |
| Orthodontic Pliers | O1-01 to O1-25, O1-101 to O1-115 | I |
| Hollowware’s | HW-001 to HW-253, HW-260 to HW-265, HW-270 to HW-313, HW-320 to HW-380, HW-390 to HW-392, HW-401 to HW-418, HW-430 to 453, i6-101 to 285, i6-01 to i6-15, i8-354 to i8-360, i8-42 to i8-49, Li-60 to Li-62 | I |
| Wire Cutting Scissors | S3-206 to S3-209 | I |
| Crown Scissors | S3-201 to S3-204 | I |
| Crown Removers | R8-01 to R8-04, R8-10, R8-11, R8-15 to R8-17, R8-21 to R8-23 | I |
| Rubber Dam Instruments (Punch, Forceps, Clamps, Frame) | ED1-00, ED1-6, ED1-9, ED1-9S, ED1-212, ED1-212A, ED1-0, ED1-1, ED1-A1, ED1-2, ED1-2A, ED1-2AS, ED1-W2, ED1-27N, ED1- 29, ED1-209, ED1-8A, ED1-8AD, ED1-W8A, ED1-10, ED1-11, ED1-14, ED1-14A, ED1-W14A, ED1-18, ED1-24, ED1-25, ED1-27, ED1-56, ED1-56S, ED1-4, ED1-W4, ED1-5, ED1-8, ED1-26N, ED1-30, ED1-31, ED1-201, ED1-205, ED1-3, ED1-ED1-W3, ED1-7, ED1-7A, ED1-W7, ED1-12A, ED1-13A, ED1-26, ED1-28, ED1-B1, ED1-B2, ED1-B3, ED1-B4, ED1-B5, ED1-B6, ED2-01 to ED2-06, ED3-01 to ED3-05 | I |
| Dental Mirror & Mirror Handles | D5-01 to D5-14, D5-20 to D5-23, D5-31 to D5-35 | I |
| Amalgam Carriers & Guns | R7-02 to R7-05, R7-10 to R7-14, R7-21 to R7-25 | I |
| Dental Syringes Cartridges | S1-01 to S1-05, S1-11 to S1-20 | I |
| Composite Instruments (Spatula, Scalars) | R1-01 to R1-03, R1-5 to R1-12, R1-15 to R1-22, F1-01 to F1-08, F2-11 to F2-20, F4-31 to F4-41, F5-51 to F5-61 | I |
| Dental Examination Set | S22-01 to S22-20 | I |
| Dental Files | P6-01 to P6-04 | I |
| Mouth Gags | S7-101 to S7-108 | I |
| Wax Knives | Li-50 to Li-55 | I |
| Tongue Depressors | S6-14 to S6-20, Li-63 | I |
| Matrix Band and Retainer | ED6-01 to ED6-08, ED6-1 to ED6-12, ED6-15, ED6-21 to ED6-24 | I |
| Suction Tubes Manual | ST-01 to ST-10 | I |
| Impression Trays | iT-01-U1 to iT-05-U5, iT-01-L1 to iT-05-L5, iT-11-U1 to iT-15-U5, iT-11-L1 to iT-15-L5, iT-21-U1 to iT-25-U5, iT-21-L1 to T-25-L5, T-31-U1 to iT-34-U4, iT-31-L1 to iT-34-L4, iT-41-U1 to iT-45-U5, iT-41-L1 to iT-45-L5, iT-S-U1P, iT-S-L1P, iT-P-U1P, iT-P-L1P, iT-61-U1 to iT-65-U5, iT-61-L1 to iT-65-L5, iT-71-U to iT-74-U4, iT-71-L1 to iT-74-L4, iT-81-U1 to iT- 84-U4, iT- 81-U1 to iT-84-L4, iT-101-L2 to iT-103-L4, iT-101-R2 to iT-103-R4, iT-104-R2 to iT-106-R4, iT-104-L2 to iT-106-L4, iT-111-S1, iT-111-P1, iT-201-P6, iT-202-S6 | I |
| Dental Chisels, Gouge and Osteotomes | P7-01 to P7-04, P7-11 to P7-16, S12-00 to S12-09, S8-101 to S8-130, S20-1 to S20-7, S20-11 to S20-18 | I |
ISO 9001 — Quality Management System
The world's most widely-recognised quality-management standard, ensuring consistent manufacturing across our entire range — not only the regulated medical instruments, but also our jewellery-making, watchmaking, beauty, hobby and craft tools.
- Certificate number: QMS1224 (Rev. 01, dated 14 August 2026)
- Initial certification: 06 August 2025
- Valid to: 05 August 2027 (certificate expiry date printed on QMS1224 Rev. 01; subject to annual surveillance)
- Issuer: YBM International DOO Skopje (UAF accredited)
Download ISO 9001 certificate (PDF)
REACH Directive — Chemical & Material Safety
EU regulation 1907/2006 (REACH) governs the registration, evaluation, authorisation and restriction of chemical substances. Our supplier's REACH declaration confirms that the steel, plating, polymer handles and surface treatments used across our catalogue meet the EU's chemical-safety requirements.
- Certificate number: IBC 9251310/9270
- Issued: 25 June 2026
- Valid until: 24 June 2027
- Issuer: IBC — validity verifiable at www.8ibc.org
Download REACH compliance declaration (PDF)
UK market
MHRA guidance (Regulating medical devices in the UK, gov.uk, updated 20 February 2026) states that self-declared CE-marked Class I medical devices conforming to EU MDR requirements can be placed on the Great Britain market until 30 June 2030, and that the government will consult on indefinite recognition of CE-marked medical devices. This section was last checked against that guidance on 25 September 2026.
Questions?
For documentation, procurement, or trade-account enquiries, please contact us. We can supply original certificates, batch traceability and conformity declarations on request to qualifying trade buyers.
