Identity
- Trade Name
- TriNEST EUDAMEDFDA UDI
- Generic Name
- Laboratory shaker IVD FDA UDI
- Device Name
- TriNEST EUDAMEDThe TriNEST™ microplate incubator and shaker is intended for use in laboratories where incubation and shaking of microplates is needed. FDA UDI
- Model / Reference
- 1296-0050 EUDAMEDFDA UDI
- Description
- The TriNEST™ microplate incubator and shaker is intended for use in laboratories where incubation and shaking of microplates is needed. FDA UDI
Identifiers
- Catalog Number
- 1296-0050 FDA UDI
- Primary DI / UDI-DI
- 06438147297726 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438147TriNEST_FV EUDAMED
- FDA Product Code
- JRQ FDA UDI
- EMDN Code
- W02079099 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Laboratory shaker IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
TriNEST by Wallac Oy — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6438147TriNEST_FV | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED 78e3da8e-b64c-4fb3-b3a2-fbe5e20bff52 61 fields · synced Jun 19, 2026
- FDA UDI 58132064-0ca0-4cbf-878a-db0026c1c974 34 fields · synced May 29, 2026