Identity
- Trade Name
- Steam Sterilisation Rolls EUDAMED
- Device Name
- Sterilisation Pouches and Rolls EUDAMED
- Model / Reference
- 6054 EUDAMED6053 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D12560542 EUDAMED+D12560532 EUDAMED
- Basic UDI-DI
- ++D125STPOUCH8Y EUDAMED
- EMDN Code
- S01020101 FLAT STERILISATION REELS, PAPER/PLASTIC FILM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Steam Sterilisation Rolls by Premium Plus (Dongguan) Limited — 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 | ++D125STPOUCH8Y | Class I | Active |
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Manufacturer
- Manufacturer
- Premium Plus (Dongguan) Limited
- EUDAMED SRN
- CN-MF-000038259
- Authorised Representative
- Premium Plus Poland sp. z o.o. PL-AR-000030110
Sources (2)
- EUDAMED dc2ea8f1-0e4f-43e1-be12-22fa926a5cde 61 fields · synced Oct 6, 2026
- EUDAMED 58834c81-a3ef-475a-9c35-4715d5a60db7 61 fields · synced May 17, 2026