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Liquid-based Thin-layer cytology processor
EUDAMEDClass A (EU MDR)
Ref YGR-LBC-04Model YGR-Z01、YGR-Z02、YGR-Z03、YGR-LBC-04
Identity
- Trade Name
- Liquid-based Thin-layer cytology processor EUDAMED
- Device Name
- Liquid-Based Thin-layer Cytology Processor EUDAMED
- Model / Reference
- YGR-Z01、YGR-Z02、YGR-Z03、YGR-LBC-04 EUDAMEDYGR-LBC-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970413352468 EUDAMED
- Basic UDI-DI
- 697041335YGR2003EU8F EUDAMED
- EMDN Code
- W02029099 VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Liquid-based Thin-layer cytology processor by Hangzhou Yiguoren 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 | 697041335YGR2003EU8F | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Yiguoren Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000003616
- Authorised Representative
- BioDomi GmbH DE-AR-000016611
Sources (1)
- EUDAMED e379ee63-12a1-4f3b-8d3c-68c76bbf86ad 61 fields · synced Jun 18, 2026