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STERIKING® ProWrap SMX-2 Blue Regular
EUDAMEDClass I (EU MDR)
Ref SMX2100Ref SMX2140Ref SMX2120/140Ref SMX2120Ref SMX2075Ref SMX2060Ref SMX2090
by Wipak Oy
Identity
- Trade Name
- STERIKING® ProWrap SMX-2 Blue Regular EUDAMED
- Device Name
- STERIKING® Wraps EUDAMED
- Model / Reference
- SMX2100 EUDAMEDSMX2140 EUDAMEDSMX2120/140 EUDAMEDSMX2120 EUDAMEDSMX2075 EUDAMEDSMX2060 EUDAMEDSMX2090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438263919168 EUDAMED06438263919199 EUDAMED06438263919182 EUDAMED06438263919175 EUDAMED06438263919144 EUDAMED06438263919137 EUDAMED06438263919151 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-2 Blue Regular 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 (7)
- EUDAMED 569b08ac-17df-4ebb-90f6-b8cf3621b6bf 61 fields · synced Aug 3, 2026
- EUDAMED 6dd80652-8650-4385-810e-cab2c0de3909 61 fields · synced May 11, 2026
- EUDAMED d681e3a7-8d95-47a1-8a68-9ce90e85e6fc 61 fields · synced May 16, 2026
- EUDAMED 9b0ffa16-d592-4714-8189-d5a6329b7689 61 fields · synced May 16, 2026
- EUDAMED ee651550-eb7b-4dce-a5db-3eb92e676090 61 fields · synced May 17, 2026
- EUDAMED f6692082-1077-4c7b-a089-938c3506c251 61 fields · synced May 18, 2026
- EUDAMED 0728f5d2-6a18-49f5-91e3-ea19134529f3 61 fields · synced May 19, 2026