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Kuohai Technology
EUDAMEDClass A (EU MDR)
Ref KH-TBModel KH-TB,KH-TP,KH-TC,KH-TS,KH-TK,KH-TD,KH-TE,KH-TH,KH-TQ,KH-TO;
Identity
- Trade Name
- KUOHAI TECHNOLOGY EUDAMED
- Device Name
- Tissue Processor EUDAMED
- Model / Reference
- KH-TB,KH-TP,KH-TC,KH-TS,KH-TK,KH-TD,KH-TE,KH-TH,KH-TQ,KH-TO; EUDAMEDKH-TB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977185070002 EUDAMED
- Basic UDI-DI
- 697718507KHTPTC EUDAMED
- Direct Marketing DI
- 06977185070002 EUDAMED
- EMDN Code
- W02029099 VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Kuohai Technology by Xiaogan Kuohai Medical 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 | 697718507KHTPTC | Class A | Active |
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Manufacturer
- Manufacturer
- Xiaogan Kuohai Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000040038
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED f5f9cb7d-a54d-4b4d-a78e-9baa0375fea6 61 fields · synced Jun 19, 2026