Identity
- Trade Name
- LR-1300B EUDAMED
- Device Name
- LR-1300B EUDAMED
- Model / Reference
- LR-1300B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00844369000222 EUDAMED
- Basic UDI-DI
- B-00844369000222 EUDAMED
- EMDN Code
- P0399 OCULAR PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
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
Lr-1300b by Lenstec Barbados Inc — Class IIb — 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-00844369000222 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Lenstec (Barbados) Inc.
- EUDAMED SRN
- BB-MF-000019262
- Authorised Representative
- CMI spol. s r.o. SK-AR-000007425
Sources (1)
- EUDAMED f09d17f6-5640-432e-a1d5-0d68347afe6a 61 fields · synced Jul 21, 2026