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Automatic Tissue Processor HP300 Plus
EUDAMEDClass A (EU MDR)
Ref 130.023.001-00Model HP300、HP300Plus
Identity
- Trade Name
- Automatic Tissue Processor HP300 Plus EUDAMED
- Device Name
- Automatic Tissue Processor EUDAMED
- Model / Reference
- HP300、HP300Plus EUDAMED130.023.001-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971182570954 EUDAMED
- Basic UDI-DI
- 69711825702VL EUDAMED
- Direct Marketing DI
- 06971182570954 EUDAMED
- EMDN Code
- W0202059010 TISSUE PROCESSORS 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
Automatic Tissue Processor HP300 Plus 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 | 69711825702VL | 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 d084676c-0b87-4ede-8bfa-691d345da565 61 fields · synced Jul 9, 2026