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FleXNeedle® Transbronchial Aspiration Needle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10005-2Model FleXNeedle (5 pack)
Identity
- Trade Name
- FleXNeedle® Transbronchial Aspiration Needle EUDAMEDFleXNeedle (5 pack) FDA UDI
- Generic Name
- Soft-tissue biopsy needle, single-use FDA UDI
- Device Name
- FleXNeedle® Transbronchial Aspiration Needle EUDAMEDSingle use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope. FDA UDI
- Model / Reference
- FleXNeedle (5 pack) EUDAMED10005-2 EUDAMEDFDA UDI
- Description
- Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope. FDA UDI
Identifiers
- Catalog Number
- 10005-2 FDA UDI
- Primary DI / UDI-DI
- 00856571007210 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00856571007210 EUDAMED
- 510(k) Number
- K090853 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- EMDN Code
- A010207 PULMONARY BIOPSY NEEDLES AND KITS EUDAMED
- GMDN Term
- Soft-tissue biopsy needle, 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 18 Gauge FDA UDI
FleXNeedle® Transbronchial Aspiration Needle by Broncus Medical Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00856571007210 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Broncus Medical, Inc.
- EUDAMED SRN
- US-MF-000027543
- Authorised Representative
- MedDevConsult GmbH DE-AR-000005877
Sources (2)
- EUDAMED 7bb923ea-2c60-4e9f-bf4d-e293d90d9c84 61 fields · synced Jul 31, 2026
- FDA UDI d384bb9e-e389-4f96-bcb6-10f3b2864e14 38 fields · synced May 30, 2026