Identity
- Trade Name
- Scleral Depressor EUDAMED
- Device Name
- Disposable Ophthalmic Depressor EUDAMED
- Model / Reference
- R6-S132-H1（SB-35074-1） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975044454352 EUDAMED
- Basic UDI-DI
- 697504445DEPRESSORXJ EUDAMED
- EMDN Code
- Q021199 OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Scleral Depressor by Sihong Ophsurin Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697504445DEPRESSORXJ | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sihong Ophsurin Co., Ltd.
- EUDAMED SRN
- CN-MF-000037458
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 5ac0ad7a-1484-4887-85e9-dab860a5cb52 61 fields · synced Jun 14, 2026