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Steam Sterilisation Pouches
EUDAMEDClass I (EU MDR)
Ref 6009Ref 6007Ref 6000Ref 6003
Identity
- Trade Name
- Steam Sterilisation Pouches EUDAMED
- Device Name
- Sterilisation Pouches and Rolls EUDAMED
- Model / Reference
- 6009 EUDAMED6007 EUDAMED6000 EUDAMED6003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D12560092 EUDAMED+D12560072 EUDAMED+D12560002 EUDAMED+D12560032 EUDAMED
- Basic UDI-DI
- ++D125STPOUCH8Y EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- S01010101 STERILISATION POUCHES, FLAT, 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 Pouches 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 (4)
- EUDAMED fcea4e41-df78-4411-821a-fec7c2c0caf9 61 fields · synced Jul 14, 2026
- EUDAMED ddd382cc-d987-4444-b7f6-556d979da2f6 61 fields · synced May 18, 2026
- EUDAMED bd090481-9796-4606-a3cc-2957a6c5fd2c 61 fields · synced May 18, 2026
- EUDAMED 1e346bcf-9413-4820-a048-fcc974b98476 61 fields · synced May 19, 2026