Identity
- Device Name
- TISSUE MICROTOME EUDAMED
- Model / Reference
- KH-Q280 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977185070101 EUDAMED
- Basic UDI-DI
- 697718507KHTMT6 EUDAMED
- EMDN Code
- W0202059005 MICROTOMES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Tissue Microtome 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 (1)
- EUDAMED ff9c76a2-1450-4242-b09c-517e59c1b60d 61 fields · synced Jun 19, 2026