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CeroFrict
EUDAMEDFDA UDIClass I (EU MDR)
Ref SML003-FJ09Model SML001-PT12, SML002-LP09, SML003-FJ09
Identity
- Trade Name
- CeroFrict EUDAMEDFDA UDI
- Generic Name
- Endoscope flushing/rinsing sink system FDA UDI
- Device Name
- Air Water Channel Cleaning Adapter EUDAMEDFDA UDI
- Model / Reference
- SML001-PT12, SML002-LP09, SML003-FJ09 EUDAMEDSML003-FJ09 EUDAMEDFDA UDI
- Description
- Air Water Channel Cleaning Adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897129990024 EUDAMEDFDA UDI
- Basic UDI-DI
- 489712999CA3K EUDAMED
- FDA Product Code
- MNL FDA UDI
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Endoscope flushing/rinsing sink system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Gastro-urological guidewire, single-use
CeroFrict by SML Med-Tech Solutions Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Gastro-urological guidewire, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 489712999CA3K | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED 2a48f432-5519-49df-bdbf-62259c86a977 61 fields · synced May 30, 2026
- FDA UDI 3acdd397-ac52-4ad8-8366-79565bed052b 33 fields · synced May 30, 2026