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Hyper Epitope Retrieval Solution
EUDAMEDClass A (EU MDR)
Ref 500mL/bottle ：LBP-IHC.BF06-18-CEModel 500mL/bottle
Identity
- Device Name
- Hyper Epitope Retrieval Solution EUDAMED
- Model / Reference
- 500mL/bottle EUDAMED500mL/bottle ：LBP-IHC.BF06-18-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948500937409 EUDAMED
- Basic UDI-DI
- 69485009IHC007KY 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
Hyper 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 | 69485009IHC007KY | 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 335f7ca8-6f14-4754-a608-bcddcb54901c 61 fields · synced Oct 7, 2026