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Fully Automated IHC & ISH Staining System
EUDAMEDClass A (EU MDR)
Ref CCP.000133Model Hyper S9 Hyper S5 ( 99-121V) Hyper S5 ( 198-242V)
Identity
- Device Name
- Fully Automated IHC & ISH Staining System EUDAMED
- Model / Reference
- Hyper S9 Hyper S5 ( 99-121V) Hyper S5 ( 198-242V) EUDAMEDCCP.000133 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948500936730 EUDAMED
- Basic UDI-DI
- 69485009IHC001KL EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Fully Automated IHC & ISH Staining System 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 Unknown
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69485009IHC001KL | Class A | Unknown |
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Manufacturer
- EUDAMED SRN
- CN-MF-000026786
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (2)
- EUDAMED 54d83d04-bc01-41a4-8aa3-3f4ae537e35d 61 fields · synced Oct 7, 2026
- EUDAMED ed32d0b3-6ef3-468d-993f-5375bd56d980 61 fields · synced Jul 21, 2026