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CeroFrict
EUDAMEDFDA UDIClass I (EU MDR)
Ref SML007-TP01Model SML007-TP01, SML007-TP02
Identity
- Trade Name
- CeroFrict EUDAMEDFDA UDI
- Generic Name
- Instrument hygienic-transportation bag FDA UDI
- Device Name
- Disposable Endoscope Tip Protector EUDAMEDFDA UDI
- Model / Reference
- SML007-TP01, SML007-TP02 EUDAMEDSML007-TP01 EUDAMEDFDA UDI
- Description
- Disposable Endoscope Tip Protector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897129990109 EUDAMEDFDA UDI
- Basic UDI-DI
- 489712999TP64 EUDAMED
- FDA Product Code
- FFY FDA UDI
- EMDN Code
- Z12029099 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER EUDAMED
- GMDN Term
- Instrument hygienic-transportation bag 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 | 489712999TP64 | 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 f275cf02-5598-4c1c-b777-779d447c8e62 61 fields · synced Jul 30, 2026
- FDA UDI 441c2ccc-5b51-44d6-a1ce-fe97af2196cc 33 fields · synced May 30, 2026