Identity
- Trade Name
- Castroviejo Speculum EUDAMEDFDA UDI
- Generic Name
- Eyelid speculum, reusable FDA UDI
- Device Name
- Eye Speculum EUDAMED
- Model / Reference
- E4041 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04058935012649 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04058935012649 EUDAMED
- FDA Product Code
- HNC FDA UDI
- EMDN Code
- L17010199 OCULAR DILATORS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Eyelid speculum, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Castroviejo Speculum by Bausch & Lomb GmbH — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04058935012649 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bausch & Lomb GmbH
- EUDAMED SRN
- DE-MF-000009142
Sources (2)
- EUDAMED 938738b8-ad8e-4a19-97c0-ac36cf3c8396 61 fields · synced Jun 19, 2026
- FDA UDI de226f89-7e96-4cc5-9048-a4e0e0487fd6 32 fields · synced May 30, 2026