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Kuohai Technology
EUDAMEDClass A (EU MDR)
Ref KH-Q325Ref KH-Q390Ref KH-Q300Ref KH-Q350Ref KY-H(35ml)Model KY-H(35ml) KY-R(30ml) KY-E(25ml) KY-F(28ml) KY-A(20ml) KY-B(17ml) KY-C(15ml) KY-D(12ml) KY-G(10ml)Ref KH-Q380Ref KH-Q330Ref KH-Q310Ref KH-Q320Ref KH-Q370Ref KCT-05Model KCT-05 KCT-06 KCT-07 KCT-08 KCT-10 KCT-11 KCT-12 KCT-13 KCT-14 KCT-15 KCT-16 KCT-17 KCT-18 KCT-19 KCT-20
Identity
- Trade Name
- KUOHAI TECHNOLOGY EUDAMED
- Device Name
- TISSUE MICROTOME EUDAMEDCell Preservation Solution EUDAMEDLiquid Based Cytology Processor EUDAMED
- Model / Reference
- KH-Q325 EUDAMEDKH-Q390 EUDAMEDKH-Q300 EUDAMEDKH-Q350 EUDAMEDKY-H(35ml) KY-R(30ml) KY-E(25ml) KY-F(28ml) KY-A(20ml) KY-B(17ml) KY-C(15ml) KY-D(12ml) KY-G(10ml) EUDAMEDKY-H(35ml) EUDAMEDKH-Q380 EUDAMEDKH-Q330 EUDAMEDKH-Q310 EUDAMEDKH-Q320 EUDAMEDKH-Q370 EUDAMEDKCT-05 KCT-06 KCT-07 KCT-08 KCT-10 KCT-11 KCT-12 KCT-13 KCT-14 KCT-15 KCT-16 KCT-17 KCT-18 KCT-19 KCT-20 EUDAMEDKCT-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977185070149 EUDAMED06977185070194 EUDAMED06977185070118 EUDAMED06977185070163 EUDAMED06977185070507 EUDAMED06977185070187 EUDAMED06977185070156 EUDAMED06977185070125 EUDAMED06977185070132 EUDAMED06977185070170 EUDAMED06977185070590 EUDAMED
- Basic UDI-DI
- 697718507KHTMT6 EUDAMED697718507KHCPSRE EUDAMED697718507KHLBCPTZ EUDAMED
- EMDN Code
- W0202059005 MICROTOMES EUDAMEDW01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMEDW02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMEDSpain EUDAMEDBelgium EUDAMEDCroatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
New Device
Yes
EUDAMEDEUDAMED
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 | 697718507KHTMT6 | 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 (11)
- EUDAMED 6e20e0e6-014f-46bd-93dc-430924a5efcd 61 fields · synced Jul 31, 2026
- EUDAMED 8170c366-23ac-4233-983e-024257992408 61 fields · synced May 17, 2026
- EUDAMED efa3a891-78ec-44d7-b113-2f94ed11286b 61 fields · synced May 17, 2026
- EUDAMED 857c86db-bb0e-43b6-b448-b7c2b85a4727 61 fields · synced May 17, 2026
- EUDAMED 3eab750b-e766-43ec-8875-bddec3e30a4e 61 fields · synced May 17, 2026
- EUDAMED 4d99582e-520a-4cfc-a2c4-ef5febff21b5 61 fields · synced May 17, 2026
- EUDAMED 1413f171-5fe9-4e14-a2cc-caf69e0f52d8 61 fields · synced May 18, 2026
- EUDAMED 88c1337e-1901-4e67-8f8d-4e1d5bc6ce3b 61 fields · synced May 18, 2026
- EUDAMED 6cca176f-aee3-4a5b-b1a0-33e69692abef 61 fields · synced May 18, 2026
- EUDAMED 83db3135-224d-4bb9-9b14-b10a5c839b25 61 fields · synced May 18, 2026
- EUDAMED b3609308-c8ae-4aab-bf62-03f37075c71e 61 fields · synced May 18, 2026