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Hematoxylin-Eosin Staining Solution (H-E)
EUDAMEDClass A (EU MDR)
Ref CP.001.910Model 100 tests/kit
Identity
- Device Name
- Hematoxylin-Eosin Staining Solution (H-E) EUDAMED
- Model / Reference
- 100 tests/kit EUDAMEDCP.001.910 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948500936259 EUDAMED
- Basic UDI-DI
- 69485009LBP007MY EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Hematoxylin-Eosin Staining Solution (H-E) by Guangzhou LBP Medicine Science & Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 69485009LBP007MY | Class A | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000026786
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED e4dd5ee5-eaf9-4bbf-bd3d-0d0239f97b50 61 fields · synced Oct 6, 2026