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5.5 x 34CM XL ADVANTAGE LOUPE
EUDAMEDClass I (EU MDR)
Ref 2113-P-6028Ref 2113-P-6012
by Keeler Ltd
Identity
- Trade Name
- 5.5 x 34CM XL ADVANTAGE LOUPE EUDAMED5.5 x 34CM XL ADVANTAGE LOUPE ON BAR EUDAMED
- Device Name
- Loupes and frames EUDAMED
- Model / Reference
- 2113-P-6028 EUDAMED2113-P-6012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272704564 EUDAMED05055272714556 EUDAMED
- Basic UDI-DI
- 50552727LOUPEFRAMEDB EUDAMED
- Direct Marketing DI
- 05055272704564 EUDAMED05055272714556 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMEDSpain 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
5.5 x 34CM XL ADVANTAGE LOUPE 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 (2)
- EUDAMED edc8d280-5e1f-46d1-82f6-9b1adedd207b 61 fields · synced Jul 18, 2026
- EUDAMED e546cbc4-2416-4835-8f58-ed9a0c588068 61 fields · synced May 18, 2026