Identity
- Trade Name
- Syringe/ HVE Sleeves EUDAMED
- Device Name
- Barrier Sleeves EUDAMED
- Model / Reference
- 100B EUDAMED100C EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125100B2 EUDAMED+D125100C2 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
Syringe/ HVE 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 d2eb5586-6da5-49d6-b04c-1abbb32ff8bb 61 fields · synced Jul 15, 2026
- EUDAMED 36eb0450-f541-4fb0-97fc-a727b1b2ce15 61 fields · synced May 18, 2026