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Flexible Videoscopes
EUDAMEDClass IIa (EU MDR)
Ref 103020004100Model TIC-I4Ref ENF-120P1Model ENF-120P1, ENF-120P2, ENF-120, ENF-120TRef PL-F520Model 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-SF520Ref PL-SF520Ref EBM-120T2LRModel EBM-120P1R, EBM-120P2R, EBM-120P3R, EBM-120MR, EBM-120LR, EBM-120T1MR, EBM-120T1LR, EBM-120T2MR, EBM-120T2LR, EBM-120T3RRef ENF-120Ref EBM-120P2RRef ENF-120P2Ref 103020004000Model TIC-I3Ref EBM-120T1LRRef EBM-120T3RRef TIC-I1Ref EBM-120P1RRef PL-F260Ref TIC-I5Ref EBM-120LRRef 103020007000Model PL-F320
Identity
- Trade Name
- Flexible Videoscopes EUDAMED
- Device Name
- Flexible Videoscopes EUDAMED
- Model / Reference
- TIC-I4 EUDAMED103020004100 EUDAMEDENF-120P1, ENF-120P2, ENF-120, ENF-120T EUDAMEDENF-120P1 EUDAMEDTIC-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-F520 EUDAMEDPL-SF520 EUDAMEDEBM-120P1R, EBM-120P2R, EBM-120P3R, EBM-120MR, EBM-120LR, EBM-120T1MR, EBM-120T1LR, EBM-120T2MR, EBM-120T2LR, EBM-120T3R EUDAMEDEBM-120T2LR EUDAMEDENF-120 EUDAMEDEBM-120P2R EUDAMEDENF-120P2 EUDAMEDTIC-I3 EUDAMED103020004000 EUDAMEDEBM-120T1LR EUDAMEDEBM-120T3R EUDAMEDTIC-I1 EUDAMEDEBM-120P1R EUDAMEDPL-F260 EUDAMEDTIC-I5 EUDAMEDEBM-120LR EUDAMEDPL-F320 EUDAMED103020007000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937048201561 EUDAMED06937048212284 EUDAMED06937048209413 EUDAMED06937048209468 EUDAMED06937048212451 EUDAMED06937048212307 EUDAMED06937048212383 EUDAMED06937048212291 EUDAMED06937048201554 EUDAMED06937048212437 EUDAMED06937048212468 EUDAMED06937048209376 EUDAMED06937048209352 EUDAMED06937048212376 EUDAMED06937048209383 EUDAMED06937048209345 EUDAMED06937048212413 EUDAMED06970283489073 EUDAMED
- Basic UDI-DI
- B-06937048201561 EUDAMED697028348UE000030J6 EUDAMED697028348UE000019JJ EUDAMED697028348UE000029JM EUDAMEDB-06937048201554 EUDAMEDB-06970283489073 EUDAMED
- EMDN Code
- Z12021004 VIDEO LARYNGOSCOPES EUDAMEDZ12021006 VIDEO NASOPHARYNGO/LARYNGOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Italy EUDAMEDSpain EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMEDEUDAMED
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 IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06937048201561 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-06937048201561 | Class IIa | 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 (18)
- EUDAMED df121cde-c82e-4801-817e-9dcc69d10e45 61 fields · synced Aug 1, 2026
- EUDAMED a2ccd253-3540-4a64-9b1f-62dbeba56305 61 fields · synced May 16, 2026
- EUDAMED c881a1cf-94b3-46b7-aa6f-792bf68faa66 61 fields · synced May 16, 2026
- EUDAMED 5a5749c1-8299-4765-a991-dd760586f892 61 fields · synced May 16, 2026
- EUDAMED f81e1834-8078-4489-b580-38ef51960363 61 fields · synced May 17, 2026
- EUDAMED 754ea170-ed06-4e16-9fe8-59971a4af554 61 fields · synced May 17, 2026
- EUDAMED b87e6edd-1498-4f67-84dc-3f5a61eba0b8 61 fields · synced May 17, 2026
- EUDAMED 49fa9db7-0da7-4942-b1a0-1997784400b9 61 fields · synced May 17, 2026
- EUDAMED 51928961-4194-47ec-bdb1-89f2a647b842 61 fields · synced May 18, 2026
- EUDAMED a26751da-024a-4fef-94b1-9ddadfcfa554 61 fields · synced May 18, 2026
- EUDAMED 5abf60e9-a4cc-4988-8dc2-2d6793e44ca4 61 fields · synced May 18, 2026
- EUDAMED a7c22c1c-71d6-43d6-b528-c90cb25d4011 61 fields · synced May 18, 2026
- EUDAMED a3c41700-eda8-43ce-9dbe-761b094860a2 61 fields · synced May 18, 2026
- EUDAMED b98d3bb7-ac22-401a-b5db-957f2f562442 61 fields · synced May 18, 2026
- EUDAMED 5e227789-0304-4a2e-b8d8-614390916a77 61 fields · synced May 18, 2026
- EUDAMED 8158f37a-97cc-4336-a5a3-31f3c71b1730 61 fields · synced May 18, 2026
- EUDAMED 31c7aad6-fd82-4a05-8c2a-4614209512d2 61 fields · synced May 18, 2026
- EUDAMED 7d3699f4-84b6-4722-9e90-e3775efc4ba3 61 fields · synced May 19, 2026