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PocketTens (HV-F013-E)
EUDAMEDClass IIa (EU MDR)
Ref PocketTens (HV-F013-E)Model HV-F013-E
Identity
- Trade Name
- PocketTens (HV-F013-E) EUDAMED
- Device Name
- PocketTens EUDAMED
- Model / Reference
- HV-F013-E EUDAMEDPocketTens (HV-F013-E) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672111660 EUDAMED
- Basic UDI-DI
- 40156721116658 EUDAMED
- EMDN Code
- Z12062899 NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
PocketTens (HV-F013-E) by OMRON Healthcare 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 | 40156721116658 | Class IIa | Active |
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Manufacturer
- Manufacturer
- OMRON Healthcare Co., Ltd.
- EUDAMED SRN
- JP-MF-000007213
- Authorised Representative
- OMRON Healthcare Europe B.V. NL-AR-000002683
Sources (1)
- EUDAMED 39406656-03d5-4918-8afe-ff846e4e7983 61 fields · synced Jul 9, 2026