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Perfect PFE (Nordic)
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref K-PPFE-NORDIC
by TensCare Ltd
Identity
- Trade Name
- Perfect PFE (Nordic) EUDAMED
- Device Name
- Perfect PFE EUDAMED
- Model / Reference
- K-PPFE-NORDIC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05033435134007 EUDAMED
- Basic UDI-DI
- 5033435K00053ZK EUDAMED
- EMDN Code
- U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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 PFE (Nordic) by TensCare Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191312 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 5033435K00053ZK | Class IIa | Active |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- GB-MF-000004156
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 925be044-a2e1-48da-893c-b42148e0835d 61 fields · synced Jul 9, 2026
- FDA 510(k) K191312 1 fields · synced May 18, 2026