Identity
- Trade Name
- CEROFRICT® EUDAMED
- Device Name
- Disposable Endoscope Valve Sets EUDAMED
- Model / Reference
- SML003-FJ EUDAMEDSML003-FJ21 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897129991120 EUDAMED
- Basic UDI-DI
- 489712999SML003UZ EUDAMED
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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: Gastro-urological guidewire, single-use
Cerofrict® by SML Med-Tech Solutions Limited — Class IIa — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Gastro-urological guidewire, single-use.
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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 | 489712999SML003UZ | Class IIa | 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 e85a445f-a987-4077-988e-abb9f532fb0f 61 fields · synced Oct 7, 2026