Identity
- Device Name
- Sterile Semi-Automatic Biopsy Needle EUDAMED
- Model / Reference
- UBN-1620 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62851002143888 EUDAMED
- Basic UDI-DI
- 62851UBN-16204P EUDAMED
- EMDN Code
- A010299 BIOPSY NEEDLES AND KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Needle guide, single-use
Sterile Semi-Automatic Biopsy Needle by Saudi Mais Co. For Medical products — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Needle guide, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 62851UBN-16204P | Class IIa | Active |
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Manufacturer
- Manufacturer
- Saudi Mais Co. For Medical products
- EUDAMED SRN
- SA-MF-000025189
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 7477b49a-624a-41b7-b420-c407ab7ea656 61 fields · synced Jul 10, 2026