Identity
- Trade Name
- Speculum eye Barraquer adult heavy wire EUDAMED
- Device Name
- Eye Speculum EUDAMED
- Model / Reference
- 52121H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04058935007331 EUDAMED
- Basic UDI-DI
- B-04058935007331 EUDAMED
- EMDN Code
- L17010199 OCULAR DILATORS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Speculum eye Barraquer adult heavy wire by Bausch & Lomb GmbH — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04058935007331 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bausch & Lomb GmbH
- EUDAMED SRN
- DE-MF-000009142
Sources (1)
- EUDAMED 794688c1-897b-47a2-9d0d-c27b2feff9a0 61 fields · synced Jul 10, 2026