Identity
- Trade Name
- Instrument Tray Sleeves EUDAMED
- Device Name
- Barrier Sleeves EUDAMED
- Model / Reference
- 101 EUDAMED102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D1251012 EUDAMED+D1251022 EUDAMED
- Basic UDI-DI
- ++D125BRSLEEVE2W EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER 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
Instrument Tray Sleeves 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 | ++D125BRSLEEVE2W | 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 ad9c1b43-bb45-4f4b-bae0-55a9a4b5a083 61 fields · synced Jul 18, 2026
- EUDAMED 92313431-29e1-4111-96d3-3683d700cb69 61 fields · synced May 19, 2026