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Set of 22 prisms square shape – includes Red Lens
EUDAMEDClass I (EU MDR)
Ref 8630-1200-14
Identity
- Trade Name
- Set of 22 prisms square shape – includes Red Lens EUDAMED
- Device Name
- Prisms for Optometry EUDAMED
- Model / Reference
- 8630-1200-14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664188000473 EUDAMED
- Basic UDI-DI
- 13664188000398MN EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Set of 22 prisms square shape – includes Red Lens by Luneau Technology Operations — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 13664188000398MN | Class I | Active |
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Manufacturer
- Manufacturer
- Luneau Technology Operations
- EUDAMED SRN
- FR-MF-000009091
Sources (1)
- EUDAMED b3bf328c-f0b2-4e4f-8fb5-da8612a0cde2 61 fields · synced Jul 22, 2026