← Back to catalogue
3.5 x 42CM XL ADVANTAGE LOUPE
EUDAMEDClass I (EU MDR)
Ref 2113-P-6021Ref 2113-P-2005
by Keeler Ltd
Identity
- Trade Name
- 3.5 x 42CM XL ADVANTAGE LOUPE EUDAMED
- Device Name
- Loupes and frames EUDAMED
- Model / Reference
- 2113-P-6021 EUDAMED2113-P-2005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272704496 EUDAMED05055272704311 EUDAMED
- Basic UDI-DI
- 50552727LOUPEFRAMEDB EUDAMED
- Direct Marketing DI
- 05055272704496 EUDAMED05055272704311 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMEDTürkiye 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
3.5 x 42CM 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Keeler Ltd
- EUDAMED SRN
- GB-MF-000009031
- Authorised Representative
- Keeler Europe Distribution, S.L. ES-AR-000001559
Sources (2)
- EUDAMED 01e491b7-3675-4829-8927-c9cb259849aa 61 fields · synced Jul 18, 2026
- EUDAMED 22db0b52-f7cd-4b5d-a58c-7b55156386fc 61 fields · synced May 18, 2026