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EUROLIGHT E30, 2.5V ophthalmoscope with clic-closure
EUDAMEDFDA UDIClass I (EU MDR)
Ref 01.21300.001
Identity
- Trade Name
- EUROLIGHT E30, 2.5V ophthalmoscope with clic-closure EUDAMEDFDA UDI
- Generic Name
- Direct ophthalmoscope FDA UDI
- Device Name
- Ophthalmoscope EUDAMED
- Model / Reference
- 01.21300.001 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 01.21300.001 FDA UDI
- Primary DI / UDI-DI
- 04030155000392 EUDAMEDFDA UDI
- Basic UDI-DI
- 4030155KaWe0102YT EUDAMED
- 510(k) Number
- K070270 FDA UDI
- FDA Product Code
- HLJ FDA UDI
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
- GMDN Term
- Direct ophthalmoscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1570 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
EUROLIGHT E30, 2.5V ophthalmoscope with clic-closure 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 | 4030155KaWe0102YT | 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 43bc6431-9f2b-4289-8bf4-60207c820b28 61 fields · synced Jun 19, 2026
- FDA UDI 9dd802c6-6b2b-43ff-a1af-eac4cd9c79e3 34 fields · synced May 30, 2026