Identity
- Trade Name
- CT520 EUDAMED
- Device Name
- Cryostat Microtome EUDAMED
- Model / Reference
- 6250、CT520 EUDAMED130.019.001-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971182571098 EUDAMED
- Basic UDI-DI
- 69711825707VW EUDAMED
- Direct Marketing DI
- 06971182571098 EUDAMED
- EMDN Code
- W0202059003 CRYOSTAT MICROTOMES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Ct520 by Dakewe (Shenzhen) Medical Equipment Co., Ltd. — 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 | 69711825707VW | Class A | Active |
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Manufacturer
- Manufacturer
- Dakewe (Shenzhen) Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000009696
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e9c17469-2c0e-4773-b532-ec61e834ddb5 61 fields · synced Jul 9, 2026