Identity
- Device Name
- Disposable Ophthalmic Needle Holders EUDAMED
- Model / Reference
- S12011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974482530413 EUDAMED
- Basic UDI-DI
- B-06974482530413 EUDAMED697448253S12000A3 EUDAMED
- EMDN Code
- Q021105 OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
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
S12011 by Ophmed Co., Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06974482530413 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06974482530413 | Class I | Active |
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Manufacturer
- Manufacturer
- Ophmed Co., Ltd.
- EUDAMED SRN
- CN-MF-000032262
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 83a1fa0a-be13-42b7-8b31-fc72f395317e 61 fields · synced Jul 20, 2026
- EUDAMED d1e0af3a-7191-447d-abd2-bc2065f87e1f 61 fields · synced May 19, 2026