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BASIC-SET COMBILIGHT C10/E10 ophthalmoscope and otoscope
EUDAMEDFDA UDIClass I (EU MDR)
Ref 02.11001.002
Identity
- Trade Name
- BASIC-SET COMBILIGHT C10/E10 ophthalmoscope and otoscope EUDAMEDFDA UDI
- Generic Name
- Otoscope, direct FDA UDI
- Device Name
- Otoscopes and diagnostic sets EUDAMED
- Model / Reference
- 02.11001.002 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 02.11001.002 FDA UDI
- Primary DI / UDI-DI
- 04030155001542 EUDAMEDFDA UDI
- Basic UDI-DI
- 4030155KaWe0101YR EUDAMED
- FDA Product Code
- HLJ FDA UDIERA FDA UDI
- EMDN Code
- Z12021007,Z12120114 EUDAMED
- GMDN Term
- Otoscope, direct FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1570 FDA UDI874.4770 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
BASIC-SET COMBILIGHT C10/E10 ophthalmoscope and otoscope by Kirchner & Wilhelm GmbH + Co KG — 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 | 4030155KaWe0101YR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Kirchner & Wilhelm GmbH + Co KG
- EUDAMED SRN
- DE-MF-000006338
Sources (2)
- EUDAMED 0ad38356-3f75-4366-b883-846db1da2ba2 61 fields · synced Oct 6, 2026
- FDA UDI 96cf98e9-de20-4300-929b-399fab4b5e80 33 fields · synced May 30, 2026