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SPECTRA IRIS ON BLACK SPORT FRAME WITH LARGE TEMPLES (130mm)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1205-P-2012
by Keeler Ltd
Identity
- Trade Name
- SPECTRA IRIS ON BLACK SPORT FRAME WITH LARGE TEMPLES (130mm) EUDAMEDSpectra Iris & small black frame FDA UDI
- Generic Name
- Indirect binocular ophthalmoscope FDA UDI
- Device Name
- Indirect Ophthalmoscope EUDAMED
- Model / Reference
- 1205-P-2012 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055272711807 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552727INDOSCOPES5Q EUDAMED
- Direct Marketing DI
- 05055272711807 EUDAMED
- FDA Product Code
- HLJ FDA UDI
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
- GMDN Term
- Indirect binocular ophthalmoscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1570 FDA UDI
- Market of Registration
- Norway EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
SPECTRA IRIS ON BLACK SPORT FRAME WITH LARGE TEMPLES (130mm) by Keeler Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50552727INDOSCOPES5Q | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 943f4a12-126d-4e27-8aec-25ae9680fb27 61 fields · synced Aug 2, 2026
- FDA UDI e6f72cd6-ce21-458c-a71d-3a5e21528c3e 32 fields · synced May 30, 2026