Identity
- Trade Name
- Katsura Biological Coporation EUDAMED
- Device Name
- M32 Nucleic Acid Extractor EUDAMED
- Model / Reference
- A-20-M03201 EUDAMEDM32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719883180322 EUDAMED
- Basic UDI-DI
- 471988318M32N8 EUDAMED
- EMDN Code
- W02050106 DNA GENOMIC PREPARATION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Katsura Biological Coporation by Katsura Biological Corp — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 471988318M32N8 | Class A | Active |
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Manufacturer
- Manufacturer
- Katsura Biological Corp
- EUDAMED SRN
- TW-MF-000044228
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED e62ea2b2-52e2-4bd0-baba-79bfaa6694df 61 fields · synced Jun 17, 2026