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Bc-P16021
EUDAMEDClass IIa (EU MDR)
Ref BC-P16021Model Single-use Flexible Bronchoscope: BC-S1E00, BC-S1H00, BC-S1J00,BC-S1E00-L, BC-S1H00-L, BC-S1J00-L，BC-E1C10、BC-E1C11、BC-E1C12、BC-E1E10、BC-E1E11、BC-E1E12、BC-E1H10、BC-E1H11、BC-E1H12、Single-use sampler: S-20mL、S-30mL、S-50mL
Identity
- Trade Name
- BC-P16021 EUDAMED
- Device Name
- Single-use Flexible Bronchoscope EUDAMED
- Model / Reference
- Single-use Flexible Bronchoscope: BC-S1E00, BC-S1H00, BC-S1J00,BC-S1E00-L, BC-S1H00-L, BC-S1J00-L，BC-E1C10、BC-E1C11、BC-E1C12、BC-E1E10、BC-E1E11、BC-E1E12、BC-E1H10、BC-E1H11、BC-E1H12、Single-use sampler: S-20mL、S-30mL、S-50mL EUDAMEDBC-P16021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972197482584 EUDAMED
- Basic UDI-DI
- 697219748BC2X EUDAMED
- EMDN Code
- Z12020802 VIDEO BRONCHOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Bc-P16021 by Hunan Vathin Medical Instrument Co., Ltd. — Class IIa — 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 | 697219748BC2X | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hunan Vathin Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000002593
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 1cac3f07-20c8-44e0-b06d-cb519c68b00c 61 fields · synced Jun 18, 2026