Identity
- Trade Name
- CeroFrict® EUDAMED
- Device Name
- Disposable Endoscope Valve Sets EUDAMED
- Model / Reference
- SML001-PT10-NS EUDAMEDSML003-FJ07-NS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897129991274 EUDAMED
- Basic UDI-DI
- 489712999NS5Q EUDAMED
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Tissue morcellation system handpiece, line-powered
CeroFrict® by SML Med-Tech Solutions Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Tissue morcellation system handpiece, line-powered.
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- 3-piece valve kit — GA HEALTH COMPANY LIMITED · Class I
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 | 489712999NS5Q | Class I | Active |
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Manufacturer
- Manufacturer
- SML Med-Tech Solutions Limited
- EUDAMED SRN
- CN-MF-000031313
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 900e8bd5-7519-466e-ac3a-36f03583a1b3 61 fields · synced May 22, 2026