Identity
- Trade Name
- Perfect mama+ EUDAMED
- Device Name
- Perfect Mama EUDAMED
- Model / Reference
- K-PM+ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05033435134038 EUDAMED
- Basic UDI-DI
- 5033435K00048ZS EUDAMED
- EMDN Code
- Z120622 MUSCLE STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Perfect mamaTENS is a medical device designed to be used in the home healthcare and hospital environments to provide symptomatic relief and management of acute pain in the perinatal* and postpartum period and is suitable for use by all who can control the device and understand the instructions. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Perfect mama+ 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 | 5033435K00048ZS | Class IIa | Active |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- UK-PR-000039358
Sources (1)
- EUDAMED 8e6bf1be-9a62-4980-9e26-3af1be8aed2f 61 fields · synced Jun 18, 2026