Identity
- Trade Name
- BIOPSY PUNCH EUDAMED
- Device Name
- BIOPSY PUNCH EUDAMED
- Model / Reference
- LCH-PUK-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560146928959 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
The BIOPSY PUNCH medical device is a high-quality, Class IIa instrument used in endocrine disruptor testing. This sterile device features a kit with no specifications provided and is administered by healthcare professionals without the need for medicated products or sterilization. The device has undergone standard verification and is available for purchase under trade name BIOPSY PUNCH.
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 fc42402e-4864-4316-9420-d68ca4670fe9 61 fields · synced Jul 29, 2026