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4.5 x 50CM XL ADVANTAGE LOUPE
EUDAMEDClass I (EU MDR)
Ref 2113-P-6027Ref 2113-P-6011
by Keeler Ltd
Identity
- Trade Name
- 4.5 x 50CM XL ADVANTAGE LOUPE EUDAMED4.5 x 50CM XL ADVANTAGE LOUPE ON BAR EUDAMED
- Device Name
- Loupes and frames EUDAMED
- Model / Reference
- 2113-P-6027 EUDAMED2113-P-6011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272704557 EUDAMED05055272714549 EUDAMED
- Basic UDI-DI
- 50552727LOUPEFRAMEDB EUDAMED
- Direct Marketing DI
- 05055272704557 EUDAMED05055272714549 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
4.5 x 50CM 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 5c93687c-c552-4ae4-a3fc-b0e5f016c188 61 fields · synced Sep 30, 2026
- EUDAMED 60a2c474-a278-45c4-b488-1ca453ccfcd9 61 fields · synced May 19, 2026