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Perfect mamaTENS
EUDAMEDClass IIa (EU MDR)
Ref K-PMRef E-CM50100PM
by TensCare Ltd
Identity
- Trade Name
- Perfect mamaTENS EUDAMEDPerfect MamaTENS Electrodes EUDAMED
- Device Name
- Perfect Mama EUDAMEDPerfect MamaTENS Electrodes EUDAMED
- Model / Reference
- K-PM EUDAMEDE-CM50100PM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05033435132263 EUDAMED05033435132300 EUDAMED
- Basic UDI-DI
- 5033435K00048ZS EUDAMED5033435E00010WK EUDAMED
- EMDN Code
- Z120622 MUSCLE STIMULATORS EUDAMEDN010201 TENS SYSTEM ELECTRODES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Denmark 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
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
Perfect mamaTENS 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 (2)
- EUDAMED ae7b069a-0e88-4aba-84d4-4c2dbb296a0d 61 fields · synced Jul 30, 2026
- EUDAMED d507ae97-0a20-4f0d-a98c-07141fdf8923 61 fields · synced May 17, 2026