Identity
- Trade Name
- TRIPTRAY Box eLine EUDAMED
- Device Name
- TIPTRAY Box eLine EUDAMED
- Model / Reference
- 400041 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260160470136 EUDAMED
- Basic UDI-DI
- 4260160470136RD EUDAMED
- EMDN Code
- W0503020280 PIPETTES, TIPS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
TRIPTRAY Box eLine by TEM Innovations GmbH — 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 | 4260160470136RD | Class A | Active |
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Manufacturer
- Manufacturer
- Tem Innovations GmbH
- EUDAMED SRN
- DE-MF-000012176
Sources (1)
- EUDAMED cd2e7aca-2b0e-4fee-80d7-5518f82d9397 61 fields · synced Jul 10, 2026