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Epitope Retrieval Solution
EUDAMEDClass A (EU MDR)
Ref 100mL/bottle (Series C) ：LBP-IHC.BF06-05-CEModel 2000mL/bag (Series A) 100mL/bottle (Series B) 100mL/bottle (Series C) Ref 2000mL/bag (Series A) ：LBP-IHC.BF06-01-CERef 100mL/bottle (Series B) ：LBP-IHC.BF06-03-CE
Identity
- Device Name
- Epitope Retrieval Solution EUDAMED
- Model / Reference
- 2000mL/bag (Series A) 100mL/bottle (Series B) 100mL/bottle (Series C) EUDAMED100mL/bottle (Series C) ：LBP-IHC.BF06-05-CE EUDAMED2000mL/bag (Series A) ：LBP-IHC.BF06-01-CE EUDAMED100mL/bottle (Series B) ：LBP-IHC.BF06-03-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948500937393 EUDAMED06948500937379 EUDAMED06948500937386 EUDAMED
- Basic UDI-DI
- 69485009IHC006KW 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Epitope Retrieval Solution 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 | 69485009IHC006KW | Class A | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000026786
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (3)
- EUDAMED 63f0fda0-6f6a-4113-8a52-036323eed1a3 61 fields · synced Oct 7, 2026
- EUDAMED b11baf34-073c-4d33-9597-159629faa0bd 61 fields · synced May 19, 2026
- EUDAMED 20263eb1-e391-4f9d-9ecd-f424d72d0ece 61 fields · synced May 19, 2026