Identity
- Trade Name
- Biopsy Needle EUDAMEDCook FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- Chiba Biopsy Needle EUDAMEDFDA UDI
- Model / Reference
- DCHN-18-15.0-U EUDAMEDG03954 FDA UDI
- Description
- Chiba Biopsy Needle FDA UDI
Identifiers
- Catalog Number
- DCHN-18-15.0-U FDA UDI
- Primary DI / UDI-DI
- 00827002039544 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002039544 EUDAMED
- FDA Product Code
- MJG FDA UDI
- EMDN Code
- A010299 BIOPSY NEEDLES AND KITS - OTHER EUDAMED
- GMDN Term
- Body aspiration needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Needle guide, single-use
Biopsy Needle by Cook Incorporated — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Needle guide, single-use.
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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-00827002039544 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
- EUDAMED SRN
- US-MF-000003180
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (3)
- EUDAMED 77d15edb-c2d5-43c8-bd50-81fd4aad84a3 61 fields · synced Jun 14, 2026
- FDA UDI fd6cd30b-b131-4a81-9c23-ec92161eff65 36 fields · synced May 30, 2026
- EUDAMED 919a4a9d-80f3-4169-b240-fe7605e1d8cb 61 fields · synced Jun 11, 2026