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-20-15.0 EUDAMEDG00777 FDA UDI
- Description
- Chiba Biopsy Needle FDA UDI
Identifiers
- Catalog Number
- DCHN-20-15.0 FDA UDI
- Primary DI / UDI-DI
- 00827002007772 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002007772 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
Similar devices
Also classified as Needle guide, single-use.
- Sterile Disposable Endocavity Needle Guide Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Sterile transrectal needle guide with sheath — Exact Imaging · Class II
- Sterile Disposable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
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-00827002007772 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Incorporated
- EUDAMED SRN
- US-MF-000003180
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (2)
- EUDAMED 2dbdaaa9-1ee0-47ea-91ba-fa79af0b316f 61 fields · synced Jun 8, 2026
- FDA UDI 162f47e5-058d-4ec2-b275-1a3ce7344f6b 36 fields · synced May 30, 2026