Identity
- Trade Name
- E0421 Harms Trabeculotome Set EUDAMEDHarms Trabeculotome Set FDA UDI
- Generic Name
- Trabeculotome, reusable FDA UDI
- Device Name
- Reusable devices EUDAMED
- Model / Reference
- E0421 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04058935011802 EUDAMEDFDA UDI
- Basic UDI-DI
- 4058935-000000-AC EUDAMED
- Direct Marketing DI
- 04058935011802 EUDAMED
- FDA Product Code
- HNR FDA UDI
- EMDN Code
- L1705 OPHTHALMOLOGY PROBES, REUSABLE EUDAMED
- GMDN Term
- Trabeculotome, 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
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
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
E0421 Harms Trabeculotome Set by Bausch & Lomb GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4058935-000000-AC | 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 24ad91c7-1d70-42b5-a68c-79eaddbd9ffd 61 fields · synced Jun 19, 2026
- FDA UDI 1aea5049-7f7e-42bf-b12c-4c94f4ee8b0a 32 fields · synced May 30, 2026