Identity
- Trade Name
- kongzee EUDAMED
- Device Name
- TENS and Muscle stimulator EUDAMED
- Model / Reference
- AS9026 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978452680030 EUDAMED
- Basic UDI-DI
- 06970890329026UY EUDAMED
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
Classification
- Device Class
- Class IIa 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
kongzee by Shenzhen AsTec Technology Co., Ltd — Class IIa — 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 | 06970890329026UY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen AsTec Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000031961
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 8eccc2a3-d854-41cd-a06e-2727159956fb 61 fields · synced Jul 31, 2026