Identity
- Device Name
- Biopsy Needles EUDAMED
- Model / Reference
- 1504142021E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16943030634221 EUDAMED
- Basic UDI-DI
- B-16943030634221 EUDAMED
- EMDN Code
- A01020199 NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Biopsy Needles by Medplus Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16943030634221 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medplus Inc.
- EUDAMED SRN
- CN-MF-000016416
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED a298f04a-e747-4f07-851f-70fde1f5483e 61 fields · synced Jun 18, 2026