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S-50mL
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref S-50mLModel 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
- S-50mL EUDAMEDSingle-use sampler FDA UDI
- Generic Name
- Surgical suction system collection container, single-use FDA UDI
- 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 EUDAMEDS-50mL EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972197482850 EUDAMEDFDA UDI
- Basic UDI-DI
- 697219748BC2X EUDAMED
- 510(k) Number
- K242416 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- EMDN Code
- Z12020802 VIDEO BRONCHOSCOPES EUDAMED
- GMDN Term
- Surgical suction system collection container, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
S-50mL by Hunan Vathin Medical Instrument Co., Ltd. — Class IIa — 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 | 697219748BC2X | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 41f45b22-3cd1-409c-a0bd-1e93d3a0e9bf 61 fields · synced Jul 13, 2026
- FDA UDI ebc13051-5182-47f6-adfc-106fe4d7ed37 33 fields · synced May 30, 2026