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Spectra Iris Black Regular Frame
EUDAMEDClass I (EU MDR)
Ref 2199-P-6330
by Keeler Ltd
Identity
- Trade Name
- SPECTRA IRIS BLACK REGULAR FRAME EUDAMED
- Device Name
- Loupes and frames EUDAMED
- Model / Reference
- 2199-P-6330 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272714822 EUDAMED
- Basic UDI-DI
- 50552727LOUPEFRAMEDB EUDAMED
- Direct Marketing DI
- 05055272714822 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Spectra Iris Black Regular Frame by Keeler Ltd — 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 | 50552727LOUPEFRAMEDB | Class I | Active |
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Manufacturer
- Manufacturer
- Keeler Ltd
- EUDAMED SRN
- GB-MF-000009031
- Authorised Representative
- Keeler Europe Distribution, S.L. ES-AR-000001559
Sources (1)
- EUDAMED 3cab0572-471a-486b-837a-d4d0e08af6b0 61 fields · synced Jun 19, 2026