Identity
- Trade Name
- Castroviejo Caliper EUDAMEDFDA UDI
- Generic Name
- Ophthalmic calliper FDA UDI
- Device Name
- Reusable Calipers, Gauges, Rulers EUDAMED
- Model / Reference
- E2404 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04058935011055 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04058935011055 EUDAMED
- FDA Product Code
- HOE FDA UDI
- EMDN Code
- L179001 OPHTHALMOLOGY SURGICAL GAUGES, REUSABLE EUDAMED
- GMDN Term
- Ophthalmic calliper 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
No
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
Category: Ophthalmic calliper
Castroviejo Caliper by Bausch & Lomb GmbH — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Ophthalmic calliper.
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- BR Surgical, LLC — BR SURGICAL LLC · Class I
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-04058935011055 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bausch & Lomb GmbH
- EUDAMED SRN
- DE-MF-000009142
Sources (2)
- EUDAMED 976b7336-ffa8-42ec-a8b5-a1e4ee1871fd 61 fields · synced Jul 21, 2026
- FDA UDI ac79c55c-4095-47e6-b24f-3fc5758b0ad7 32 fields · synced May 29, 2026