Identity
- Trade Name
- NEEDLE HOLDER 14cm CURVED EUDAMED
- Device Name
- NEEDLE HOLDER 14cm CURVED EUDAMED
- Model / Reference
- 1004-19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D1231004190 EUDAMED
- Basic UDI-DI
- ++D123100419W2 EUDAMED
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
NEEDLE HOLDER 14cm CURVED by Dental Expert — 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
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- 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 | ++D123100419W2 | Class I | Active |
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Manufacturer
- Manufacturer
- Dental Expert
- EUDAMED SRN
- PK-MF-000024595
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED 0bf414d2-e102-4373-9b3e-fe04eed0ca0f 61 fields · synced Jun 18, 2026