Identity
- Trade Name
- TENA Fix Acute S 60x1 pcs EUDAMED
- Device Name
- Heavy Inco 2-Piece Pants EUDAMED
- Model / Reference
- 100505 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07322541330730 EUDAMED
- Basic UDI-DI
- 7322540004006B EUDAMED
- EMDN Code
- T04010104 NET PANTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
TENA Fix Acute S 60x1 pcs by Essity Hygiene and Health AB — Class I — 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 | 7322540004006B | Class I | Active |
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Manufacturer
- Manufacturer
- Essity Hygiene and Health AB
- EUDAMED SRN
- SE-MF-000000004
Sources (1)
- EUDAMED 9167b22c-89a9-46f9-a793-0753791ba7e6 61 fields · synced Jul 26, 2026