Identity
- Trade Name
- Endo Organizer Box EUDAMED
- Device Name
- Sterilisation Containers EUDAMED
- Model / Reference
- 4825 EUDAMED4823 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D12548252 EUDAMED+D12548232 EUDAMED
- Basic UDI-DI
- ++D125STERICONTAINERS3C EUDAMED
- EMDN Code
- S010499 STERILISATION CONTAINERS - 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
Endo Organizer Box 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 | ++D125STERICONTAINERS3C | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
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 a3ff1244-2cc0-4db4-ad16-b778d5fdf00c 61 fields · synced Jul 17, 2026
- EUDAMED a4b83c0c-908a-4659-b554-5d99cfc6d650 61 fields · synced May 17, 2026