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Nextech
EUDAMEDClass IIa (EU MDR)
Ref BPS5.0 (Primary)Model Biopsy Punch- 5.0mm (Size)
Identity
- Trade Name
- Nextech EUDAMED
- Device Name
- Biopsy Punch EUDAMED
- Model / Reference
- Biopsy Punch- 5.0mm (Size) EUDAMEDBPS5.0 (Primary) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903175091601 EUDAMED
- Basic UDI-DI
- B-08903175091601 EUDAMED
- EMDN Code
- A01020302 CUTANEOUS BIOPSY PUNCHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Nextech by Paramount Surgimed Limited — 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-08903175091601 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Paramount Surgimed Limited
- EUDAMED SRN
- IN-MF-000021682
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED e12c8df2-24f2-48f4-82b2-68a2c187fcba 61 fields · synced Jun 18, 2026