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TENS & EMS Device
EUDAMEDClass I (EU MDR)
Ref GC-TE019Model GC-TE019、GC-TE020、GC-TE021、GC-TE022、GC-TE023、GC-TE024、GC-TE025、GC-TE026、GC-TE027、GC-TE028、GC-TE029、GC-TE030 etc
Identity
- Device Name
- TENS & EMS Device EUDAMED
- Model / Reference
- GC-TE019、GC-TE020、GC-TE021、GC-TE022、GC-TE023、GC-TE024、GC-TE025、GC-TE026、GC-TE027、GC-TE028、GC-TE029、GC-TE030 etc EUDAMEDGC-TE019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977563442001 EUDAMED
- Basic UDI-DI
- 697756344GCTES8 EUDAMED
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
TENS & EMS Device by Dongguan Goceng Medical Supplies Co., Ltd — 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 | 697756344GCTES8 | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Goceng Medical Supplies Co., Ltd
- EUDAMED SRN
- CN-MF-000042512
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 679ae4c2-30d2-4083-adf7-98bbe1bc22ad 61 fields · synced Jun 18, 2026