Identity
- Trade Name
- 4K.205.100 EUDAMED
- Device Name
- Telescope EUDAMED
- Model / Reference
- 4KIR.305.103 EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945868606954 EUDAMED
- Basic UDI-DI
- 694586864KIR.305.103DN EUDAMED
- Direct Marketing DI
- 06945868606954 EUDAMED
- EMDN Code
- Z12029009 LAPAROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
4k.205.100 by Sonoscape Medical Corp. — Class IIa — 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 | 694586864KIR.305.103DN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sonoscape Medical Corp.
- EUDAMED SRN
- CN-MF-000009623
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 043b78ca-7e69-4754-a892-8ee29f89f5c3 61 fields · synced Oct 6, 2026