Identity
- Trade Name
- Biopsy EUDAMED
- Device Name
- BIO (Biopsy) EUDAMED
- Model / Reference
- BIO 02 EUDAMEDSYN-BIO02-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065021834145 EUDAMED
- Basic UDI-DI
- 5065021834SYNPP014ZA EUDAMED
- EMDN Code
- A010299 BIOPSY NEEDLES AND KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Facilitates the collection of tissue samples in a sterile manner for biopsy procedures. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Needle guide, single-use
Biopsy by SYNDEO Medical — 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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- 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 (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 | 5065021834SYNPP014ZA | Class IIa | Active |
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Manufacturer
- Manufacturer
- SYNDEO Medical
- EUDAMED SRN
- BE-PR-000044136
Sources (1)
- EUDAMED a1daae02-37e0-42d5-a080-a2865bb6be81 61 fields · synced Jun 19, 2026