Identity
- Trade Name
- Healtshsky EUDAMED
- Device Name
- Multi Hopper Laser Cassette Printer EUDAMED
- Model / Reference
- EBMarker-160 EUDAMEDEMarker-11A-C100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977211623011 EUDAMED
- Basic UDI-DI
- 697721162HSMHLCPZ8 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 | 697721162HSMHLCPZ8 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou HealthSky Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000040002
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 0fdfa9db-89a2-477c-b854-28949665d68f 61 fields · synced Jun 18, 2026