Identity
- Trade Name
- Hygofol Rolls EUDAMED
- Device Name
- STERIKING® Pouches and Rolls EUDAMED
- Model / Reference
- 6020-055-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438263373335 EUDAMED
- Basic UDI-DI
- 6438263ST14010NK EUDAMED
- EMDN Code
- S01020101 FLAT STERILISATION REELS, PAPER/PLASTIC FILM 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
Hygofol Rolls 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 | 6438263ST14010NK | Class I | Active |
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Manufacturer
- Manufacturer
- Wipak Oy
- EUDAMED SRN
- FI-MF-000004496
Sources (1)
- EUDAMED a894cd23-fddb-47f5-814a-7a147fd2fa60 61 fields · synced Jun 18, 2026