Identity
- Trade Name
- MSMS Workstation EUDAMEDFDA UDI
- Generic Name
- Clinical laboratory information system FDA UDI
- Device Name
- MSMS Workstation EUDAMEDThe MSMS Workstation is intended for use as a calculator/data processing software for the storage, retrieval, and processing of mass spectrometry data. FDA UDI
- Model / Reference
- 5002-0540 EUDAMEDFDA UDI
- Description
- The MSMS Workstation is intended for use as a calculator/data processing software for the storage, retrieval, and processing of mass spectrometry data. FDA UDI
Identifiers
- Catalog Number
- 5002-0540 FDA UDI
- Primary DI / UDI-DI
- 06438147352401 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438147MSMSWs_H5 EUDAMED
- FDA Product Code
- JQP FDA UDI
- EMDN Code
- W0201010192 CHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Clinical laboratory information system FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2100 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MSMS Workstation 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 | 6438147MSMSWs_H5 | 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 f88d17c6-16a9-439f-910b-4bc8a1bc9f42 61 fields · synced Jul 31, 2026
- FDA UDI 1b822f01-1173-4c9d-a215-7ca22882242e 34 fields · synced May 29, 2026