Identity
- Device Name
- Disposable Ophthalmic Speculums EUDAMED
- Model / Reference
- S15001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974482530024 EUDAMED
- Basic UDI-DI
- B-06974482530024 EUDAMED697448253S15000AQ EUDAMED
- EMDN Code
- Q021199 OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I 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
S15001 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-06974482530024 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06974482530024 | 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 597d2565-70d8-4e6d-a8de-9ce9c6bba730 61 fields · synced Jul 25, 2026
- EUDAMED 4cf4212d-3107-48c1-b10b-f01e41e737ad 61 fields · synced May 18, 2026