Identity
- Trade Name
- BIOPSY PUNCH EUDAMED
- Device Name
- BIOPSY PUNCH EUDAMED
- Model / Reference
- 48401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560146929222 EUDAMED
- Basic UDI-DI
- 456014692AB014N EUDAMED
- EMDN Code
- A01020302 CUTANEOUS BIOPSY PUNCHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Biopsy Punch by Kai Industries Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 456014692AB014N | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kai Industries Co., Ltd.
- EUDAMED SRN
- JP-MF-000016663
- Authorised Representative
- Kai Europe GmbH DE-AR-000005096
Sources (1)
- EUDAMED 9d51fefb-86e4-4328-8d9d-734b22f26849 61 fields · synced Jul 25, 2026