Identity
- Device Name
- Disposable Ophthalmic Scissors EUDAMED
- Model / Reference
- S13001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974482530338 EUDAMED
- Basic UDI-DI
- B-06974482530338 EUDAMED697448253S13000AA EUDAMED
- EMDN Code
- Q021103 OPHTHALMIC SURGERY SCISSORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
S13001 by Ophmed Co., Ltd. — Class IIa — 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-06974482530338 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06974482530338 | Class IIa | 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 2dacaf87-6e8e-478b-89c9-d34d0121e1d5 61 fields · synced Jul 21, 2026
- EUDAMED f8301188-24e3-4c36-b9fc-5bddd3688996 61 fields · synced May 18, 2026