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CeroFrict®
EUDAMEDClass I (EU MDR)
Ref SML004-PY02-FCModel SML004-PY01, SML004-PY01-CC, SML004-PY02, SML004-PY02-FC, SML004-PY02-LC, SML004-PY03, SML004-PY04, SML004-PY05, SML004-PY06, SML004-PY07, SML004-PY08, SML004-PY09, SML004-PY10, SML004-PY11
Identity
- Trade Name
- CeroFrict® EUDAMED
- Device Name
- Disposable Polyp Trap EUDAMED
- Model / Reference
- SML004-PY01, SML004-PY01-CC, SML004-PY02, SML004-PY02-FC, SML004-PY02-LC, SML004-PY03, SML004-PY04, SML004-PY05, SML004-PY06, SML004-PY07, SML004-PY08, SML004-PY09, SML004-PY10, SML004-PY11 EUDAMEDSML004-PY02-FC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897129991328 EUDAMED
- Basic UDI-DI
- 489712999PY6A EUDAMED
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES 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: Gastro-urological guidewire, single-use
CeroFrict® by SML Med-Tech Solutions Limited — Class I — 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 | 489712999PY6A | 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 d7d9079b-3985-4a59-b146-396e8652ee44 61 fields · synced Oct 7, 2026