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Hematoxylin
EUDAMEDClass A (EU MDR)
Ref 45mL/bottle (Series B) ：LBP-IHC.BF09-06-CEModel 100mL/bottle (Series A) 45mL/bottle (Series B)
Identity
- Device Name
- Hematoxylin EUDAMED
- Model / Reference
- 100mL/bottle (Series A) 45mL/bottle (Series B) EUDAMED45mL/bottle (Series B) ：LBP-IHC.BF09-06-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948500937485 EUDAMED
- Basic UDI-DI
- 69485009IHC012KR EUDAMED
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Hematoxylin by Guangzhou LBP Medicine Science & Technology 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 | 69485009IHC012KR | 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 b4868226-2e81-40b7-a57d-a0d5078c9e9a 61 fields · synced Jun 18, 2026