Identity
- Trade Name
- BFlex™ 2 Ultraslim 2.8 EUDAMEDBFlex™ FDA UDI
- Generic Name
- Flexible video bronchoscope, single-use FDA UDI
- Device Name
- Single-Use Bronchoscopes EUDAMEDBFlex™ 2 Ultraslim 2.8 Single-Use Bronchoscope FDA UDI
- Model / Reference
- 0570-0434 EUDAMEDBFlex™ 2 Ultraslim 2.8 FDA UDI
- Description
- BFlex™ 2 Ultraslim 2.8 Single-Use Bronchoscope FDA UDI
Identifiers
- Catalog Number
- 0570-0434 FDA UDI
- Primary DI / UDI-DI
- 00879123008541 EUDAMEDFDA UDI
- Basic UDI-DI
- 087912300-0003JW EUDAMED
- 510(k) Number
- K211947 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- EMDN Code
- Z12020802 VIDEO BRONCHOSCOPES EUDAMED
- GMDN Term
- Flexible video bronchoscope, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
BFlex™ 2 Ultraslim 2.8 by Verathon Medical (Canada) ULC — 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 | 087912300-0003JW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Verathon Medical (Canada) ULC
- EUDAMED SRN
- CA-MF-000022866
- Authorised Representative
- Verathon Medical (Europe) B. V. NL-AR-000015688
Sources (2)
- EUDAMED bb1e6569-f88f-4a2a-a117-036a53c4c9ed 61 fields · synced Jun 19, 2026
- FDA UDI ae235517-68bb-4685-984d-34d4624ab717 35 fields · synced May 30, 2026