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HRP/DAB IHC Staining Kit (LBP-5548)
EUDAMEDClass A (EU MDR)
Ref 300 tests/kit ：LBP-IHC.BF13-01-CEModel 300 tests/kit 600 tests/kit 900 tests/kit
Identity
- Device Name
- HRP/DAB IHC Staining Kit (LBP-5548) EUDAMED
- Model / Reference
- 300 tests/kit 600 tests/kit 900 tests/kit EUDAMED300 tests/kit ：LBP-IHC.BF13-01-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948500937324 EUDAMED
- Basic UDI-DI
- 69485009IHC003KQ EUDAMED
- EMDN Code
- W01030710 SECONDARY ANTISERA FOR IMMUNOHISTOLOGY 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
Yes
EUDAMED
HRP/DAB IHC Staining Kit (LBP-5548) by Guangzhou LBP Medicine Science & Technology Co., Ltd. — Class A — CE/MDR — 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 | 69485009IHC003KQ | 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 fc1fe073-2be5-4dc1-9e00-18c4136fca5b 61 fields · synced Oct 6, 2026