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Tens Electrodes
EUDAMEDClass I (EU MDR)
Ref TP-B-01Model 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-10Ref TP-L-09Ref TP-L-06Ref TP-B-07Ref TP-B-10Ref TP-L-08Ref TP-L-04Ref TP-B-08Ref TP-B-04Ref TP-L-02
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-B-01 EUDAMEDTP-L-09 EUDAMEDTP-L-06 EUDAMEDTP-B-07 EUDAMEDTP-B-10 EUDAMEDTP-L-08 EUDAMEDTP-L-04 EUDAMEDTP-B-08 EUDAMEDTP-B-04 EUDAMEDTP-L-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978812870774 EUDAMED06978812870958 EUDAMED06978812870927 EUDAMED06978812870835 EUDAMED06978812870866 EUDAMED06978812870941 EUDAMED06978812870903 EUDAMED06978812870842 EUDAMED06978812870804 EUDAMED06978812870880 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 (10)
- EUDAMED 1ffb63b6-a337-460b-9a7a-4bdff9d75c2b 61 fields · synced Jul 29, 2026
- EUDAMED 1932c42f-1f17-46e0-ba52-2f9c676d19d2 61 fields · synced Jul 9, 2026
- EUDAMED 3599cdc7-79bb-40c3-9d72-ac1feb21aff9 61 fields · synced Jul 9, 2026
- EUDAMED c10ded12-0305-4df1-aadd-f9d564738921 61 fields · synced Jul 10, 2026
- EUDAMED 0b29bd3d-d232-4ad3-9ae8-a81b56eee591 61 fields · synced Jul 14, 2026
- EUDAMED be5aaec1-172d-426c-a35d-1ac079975f5f 61 fields · synced Jul 15, 2026
- EUDAMED c7e653d6-54ba-4ecb-8e86-bbd79fc39d7d 61 fields · synced Jul 16, 2026
- EUDAMED b7c73bab-42af-4d8b-8348-e051a83d7b46 61 fields · synced Jul 19, 2026
- EUDAMED 21be219f-8af5-47bf-97d9-7e3d32577495 61 fields · synced Jul 24, 2026
- EUDAMED 97625921-ddce-4db4-82c6-29b3eb722678 61 fields · synced Jul 29, 2026