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Healtshsky
EUDAMEDClass A (EU MDR)
Ref EMarker-21A-S100Model EMarker-11A-S100, EMarker-21A-S100Ref EMarker-21A-C100Model EBMarker-160Ref EMarker-21A-C600Ref EMarker-11A-S100
Identity
- Trade Name
- Healtshsky EUDAMED
- Device Name
- Laser Slide Printer EUDAMEDMulti Hopper Laser Cassette Printer EUDAMED
- Model / Reference
- EMarker-11A-S100, EMarker-21A-S100 EUDAMEDEMarker-21A-S100 EUDAMEDEBMarker-160 EUDAMEDEMarker-21A-C100 EUDAMEDEMarker-21A-C600 EUDAMEDEMarker-11A-S100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977211623059 EUDAMED06977211623028 EUDAMED06977211623035 EUDAMED06977211623042 EUDAMED
- Basic UDI-DI
- 697721162HSLSPNX EUDAMED697721162HSMHLCPZ8 EUDAMED
- EMDN Code
- W0202059017 CASSETTE / SLIDE PRINTERS 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
Healtshsky by Hangzhou HealthSky Biotechnology 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 | 697721162HSLSPNX | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou HealthSky Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000040002
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 42db21c6-07b9-4fe6-a133-5a7b047c903d 61 fields · synced Jul 11, 2026
- EUDAMED 331e25d7-41aa-4553-8b3e-b4d138fc8055 61 fields · synced May 17, 2026
- EUDAMED 50e70afe-286a-432e-ba4a-ef458a4ad395 61 fields · synced May 18, 2026
- EUDAMED 3276108a-5bb9-40c0-8840-3681058e7d36 61 fields · synced May 18, 2026