Identity
- Device Name
- Dialtec Barrier Film Wipes EUDAMED
- Model / Reference
- DTSP 4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05061025720262 EUDAMED
- Basic UDI-DI
- 506102572DTSP42V EUDAMED
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) 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
Dialtec Barrier Film Wipes by Independence Products Ltd — 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 | 506102572DTSP42V | Class I | Active |
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Manufacturer
- Manufacturer
- Independence Products Ltd
- EUDAMED SRN
- UK-MF-000038837
- Authorised Representative
- International Associates Auditing & Certification Limited IE-AR-000002248
Sources (1)
- EUDAMED 2c9add90-f501-4059-a5c6-9786f363e2c1 61 fields · synced Sep 30, 2026