Identity
- Trade Name
- ZEKcover EUDAMED
- Device Name
- Thermometer probe covers EUDAMED
- Model / Reference
- 9225 EUDAMED12028 EUDAMED001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16978574620010 EUDAMED16978574620027 EUDAMED
- Basic UDI-DI
- 6978574629225JZ EUDAMED697857462120289H EUDAMED
- Direct Marketing DI
- 16978574620010 EUDAMED16978574620027 EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ZEKcover by Kang Ze Industrial Co., Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6978574629225JZ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kang Ze Industrial Co., Limited
- EUDAMED SRN
- CN-MF-000047551
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED ee799162-b064-4acc-a78e-361078dd3126 61 fields · synced Jul 29, 2026
- EUDAMED 287f26a0-d238-47dc-b8fe-e2e1f49848de 61 fields · synced May 18, 2026