Identity
- Trade Name
- 11.101.318 EUDAMED
- Device Name
- Reusable Gas Heating Insufflation Tubing Set EUDAMED
- Model / Reference
- 11.101.318 EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945868609191 EUDAMED
- Basic UDI-DI
- 69458686F11.1019U EUDAMED
- EMDN Code
- Z12029085 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb 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
11.101.318 by Sonoscape Medical Corp. — Class IIb — 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 | 69458686F11.1019U | Class IIb | 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 f9febe28-414a-41bb-a8ef-a127261fbec3 61 fields · synced Oct 6, 2026