Identity
- Trade Name
- Portable Incubator EUDAMED
- Device Name
- Portable Incubator EUDAMED
- Model / Reference
- EASY-1T EUDAMEDSUPE01T05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521000105 EUDAMED
- Basic UDI-DI
- 697452100SUPE01TVS EUDAMED
- Direct Marketing DI
- 06974521000105 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Portable Incubator by Shenzhen Superbio Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697452100SUPE01TVS | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Superbio Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024149
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 87274e2a-b1cd-4b25-94b1-b3e1393670ea 61 fields · synced Jun 19, 2026