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Tens Electrodes
EUDAMEDClass I (EU MDR)
Ref TP-L-05Model TP-B-01,TP-B-02,TP-B-03,TP-B-04,TP-B-05,TP-B-06,TP-B-07,TP-B-08,TP-B-09,TP-B-10 TP-L-01,TP-L-02,TP-L-03,TP-L-04,TP-L-05,TP-L-06,TP-L-07,TP-L-08,TP-L-09,TP-L-10
Identity
- Device Name
- Tens Electrodes EUDAMED
- Model / Reference
- TP-B-01,TP-B-02,TP-B-03,TP-B-04,TP-B-05,TP-B-06,TP-B-07,TP-B-08,TP-B-09,TP-B-10 TP-L-01,TP-L-02,TP-L-03,TP-L-04,TP-L-05,TP-L-06,TP-L-07,TP-L-08,TP-L-09,TP-L-10 EUDAMEDTP-L-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978812870910 EUDAMED
- Basic UDI-DI
- 697881287TENSELECTRODES9Q EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE 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
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Tens Electrodes by Shanghai Heramed Tech Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697881287TENSELECTRODES9Q | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Heramed Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000048531
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 566c8904-4f67-43ac-b780-c3e6ec64f463 61 fields · synced Jun 20, 2026