Identity
- Trade Name
- Ova+ EUDAMED
- Device Name
- Ova EUDAMED
- Model / Reference
- K-OVAP EUDAMEDOva+ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05033435130917 EUDAMED05033435136322 EUDAMED
- Basic UDI-DI
- 5033435K00037ZM EUDAMED5033435K00037DSJ EUDAMED
- EMDN Code
- Z120622 MUSCLE STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
- Medical Purpose
- This device has been designed to be used in the home healthcare environment to treat symptoms of primary menstrual pain (dysmenorrhoea). The Ova+ may also help to relieve the pain of secondary menstrual pain due to conditions such as endometriosis, fibroids or pelvic inflammatory disease. 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
Ova+ by TensCare 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 | 5033435K00037ZM | Class IIa | Active |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- UK-PR-000039358
Sources (2)
- EUDAMED f9b100c7-bdf6-41cd-a7c2-340d3fb7d639 61 fields · synced Jul 18, 2026
- EUDAMED 1b892b02-4297-4679-ab7a-a1e5ab9dda96 61 fields · synced May 17, 2026