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Flexible Videoscopes
EUDAMEDClass I (EU MDR)
Ref PL-SF380Model TIC-I0,TIC-I1,TIC-I2,TIC-I3,TIC-I4,TIC-I5,PL-F260,PL-F320,PL-F400,PL-F520,PL-SF280,PL-SF380,PL-SF420,PL-SF480,PL-SF520
Identity
- Trade Name
- Flexible Videoscopes EUDAMED
- Device Name
- Flexible Videoscopes EUDAMED
- Model / Reference
- TIC-I0,TIC-I1,TIC-I2,TIC-I3,TIC-I4,TIC-I5,PL-F260,PL-F320,PL-F400,PL-F520,PL-SF280,PL-SF380,PL-SF420,PL-SF480,PL-SF520 EUDAMEDPL-SF380 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937048209437 EUDAMED
- Basic UDI-DI
- 697028348UE000019JJ EUDAMED
- EMDN Code
- Z12021006 VIDEO NASOPHARYNGO/LARYNGOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Flexible Videoscopes by Zhejiang UE Medical Corp. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697028348UE000019JJ | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang UE Medical Corp.
- EUDAMED SRN
- CN-MF-000003020
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 5c0c36a4-d814-4ddf-98a4-a4c3898de51f 61 fields · synced Jun 19, 2026