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CeroFrict®
EUDAMEDFDA UDIClass I (EU MDR)
Ref SML005-BB06Model SML005-BB01, SML005-BB02, SML005-BB03, SML005-BB04
Identity
- Trade Name
- CeroFrict® EUDAMEDCeroFrict FDA UDI
- Generic Name
- Endoscopic bite block, basic, single-use FDA UDI
- Device Name
- Disposable Bite Block EUDAMED
- Model / Reference
- SML005-BB01, SML005-BB02, SML005-BB03, SML005-BB04 EUDAMEDSML005-BB06 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897129990765 EUDAMEDFDA UDI
- Basic UDI-DI
- 489712999BB3J EUDAMED
- FDA Product Code
- MNK FDA UDI
- EMDN Code
- G030804 GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS EUDAMED
- GMDN Term
- Endoscopic bite block, basic, single-use 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
CeroFrict® by SML Med-Tech Solutions Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 489712999BB3J | 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 66e0dea0-20bc-4cfd-a05e-62d8e4dd1bbf 61 fields · synced Jul 24, 2026
- FDA UDI ebabd9c9-99e6-4ea5-a84b-9238c3354480 32 fields · synced May 30, 2026