Identity
- Device Name
- Disposable Ophthalmic Speculums EUDAMED
- Model / Reference
- S15007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974482534640 EUDAMED
- Basic UDI-DI
- 697448253S15000AQ EUDAMEDB-06974482534640 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
Disposable Ophthalmic Speculums by Ophmed Co., Ltd. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697448253S15000AQ | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697448253S15000AQ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ophmed Co., Ltd.
- EUDAMED SRN
- CN-MF-000032262
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 5c51854f-8f1c-4a74-8558-6772046197df 61 fields · synced Jun 19, 2026
- EUDAMED 7c521251-0755-464f-b0c0-8cd2996a25c7 61 fields · synced May 18, 2026