Identity
- Trade Name
- MATHIEU NEEDLE HOLDER STANDARD TIP EUDAMED
- Device Name
- INSTRUMENTS EUDAMED
- Model / Reference
- 4150-913 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056334600442 EUDAMED
- Basic UDI-DI
- 50563346INSTRUMENTRUIXB EUDAMED
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Suturing needle holder, reusable
Mathieu Needle Holder Standard Tip by Ortho-Care (UK) Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Suturing needle holder, reusable.
- JACOBSON NEEDLE HOLDER — SONTEC INSTRUMENTS, INC. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- HNM Medical — HNM STAINLESS, LLC. · Class I
- PEAK MEDICAL — PEAK MEDICAL Distribution Inc · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50563346INSTRUMENTRUIXB | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortho-Care (UK) Limited
- EUDAMED SRN
- GB-MF-000010884
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED a3b94d5c-8faf-4c0d-b514-dce33dc64c53 61 fields · synced Jul 23, 2026