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STERIKING® ProWrap SMX-4 Blue Super Duty
EUDAMEDClass I (EU MDR)
Ref SMX4150Ref SMX4075Ref SMX4140Ref SMX4100
by Wipak Oy
Identity
- Trade Name
- STERIKING® ProWrap SMX-4 Blue Super Duty EUDAMED
- Device Name
- STERIKING® Wraps EUDAMED
- Model / Reference
- SMX4150 EUDAMEDSMX4075 EUDAMEDSMX4140 EUDAMEDSMX4100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438263919410 EUDAMED06438263919366 EUDAMED06438263919809 EUDAMED06438263919380 EUDAMED
- Basic UDI-DI
- 6438263ST15010NS EUDAMED
- EMDN Code
- S010302 NON-WOVEN FABRIC FOR STERILISATION EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
STERIKING® ProWrap SMX-4 Blue Super Duty by Wipak Oy — 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 | 6438263ST15010NS | Class I | Active |
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Manufacturer
- Manufacturer
- Wipak Oy
- EUDAMED SRN
- FI-MF-000004496
Sources (4)
- EUDAMED 74791ca6-d62d-4bea-8fce-9ab3210f3137 61 fields · synced Jul 14, 2026
- EUDAMED 9a9035eb-aba6-4821-8d2e-614c308686bb 61 fields · synced May 18, 2026
- EUDAMED 8f8e8c75-56c6-436f-95bb-ec995433c5c8 61 fields · synced May 18, 2026
- EUDAMED 4309ecae-20d3-44df-a7fd-cb24309c8fe6 61 fields · synced May 19, 2026