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Automatic Tissue Processor
EUDAMEDClass A (EU MDR)
Ref 130.004001-00Model HP300、HP300Plus
Identity
- Trade Name
- Automatic Tissue Processor EUDAMED
- Device Name
- Automatic Tissue Processor EUDAMED
- Model / Reference
- HP300、HP300Plus EUDAMED130.004001-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971182570923 EUDAMED
- Basic UDI-DI
- 69711825702VL EUDAMED
- Direct Marketing DI
- 06971182570923 EUDAMED
- EMDN Code
- W0202059010 TISSUE PROCESSORS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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 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 7b806993-3796-49bd-b96f-dc2b2a2bf5de 61 fields · synced Jun 18, 2026