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Ophthalmological ultrasonic measuring instruments
EUDAMEDClass IIa (EU MDR)
Ref OD1-AP
Identity
- Trade Name
- Ophthalmological ultrasonic measuring instruments EUDAMED
- Device Name
- Ophthalmological ultrasonic measuring instruments EUDAMED
- Model / Reference
- OD1-AP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974784890017 EUDAMED
- Basic UDI-DI
- B-06974784890017 EUDAMED
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ophthalmological ultrasonic measuring instruments by Xuzhou Kaixin Electronic Instrument Co., Ltd. — Class IIa — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06974784890017 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xuzhou Kaixin Electronic Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000040932
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b9b913bb-6339-41d5-829c-94cac083732b 61 fields · synced Oct 6, 2026