Identity
- Trade Name
- Biopsy Needle EUDAMEDFranseen Biopsy Needle FDA UDI
- Generic Name
- Soft-tissue biopsy needle, single-use FDA UDI
- Device Name
- Franseen Biopsy Needle EUDAMEDFranseen Biopsy Needle 22ga x 20cm FDA UDI
- Model / Reference
- MFN2208 EUDAMEDFDA UDI
- Description
- Franseen Biopsy Needle 22ga x 20cm FDA UDI
Identifiers
- Catalog Number
- MFN2208 FDA UDI
- Primary DI / UDI-DI
- 20886333002591 EUDAMED00886333002597 FDA UDI
- Basic UDI-DI
- B-20886333002591 EUDAMED
- 510(k) Number
- K980122 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A01020102 ASPIRATION FINE 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
- 876.1075 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
Yes
FDA UDI
Category: Diskectomy system, percutaneous, automatic
Biopsy Needle by Argon Medical Devices, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-20886333002591 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
- EUDAMED SRN
- US-MF-000002324
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 78a2f194-65f7-4a84-98f1-11abdf4f38a3 61 fields · synced Jul 31, 2026
- FDA UDI 5b0b4e3c-eacd-4282-8312-791a968c0510 38 fields · synced May 30, 2026