Identity
- Device Name
- myPKFiT for Healthcare Professionals EUDAMED
- Model / Reference
- v3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850025688314 EUDAMED
- Basic UDI-DI
- 0850025688myPKFiT_HCPsEF EUDAMED
- EMDN Code
- Z12040292 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria 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
myPKFiT for Healthcare Professionals by Takeda Pharmaceuticals U.S.A., Inc. — Class IIa — 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 | 0850025688myPKFiT_HCPsEF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Takeda Pharmaceuticals U.S.A., Inc.
- EUDAMED SRN
- US-MF-000014749
- Authorised Representative
- Shire Pharmaceuticals Ireland Limited IE-AR-000000593
Sources (1)
- EUDAMED 3f2a9dbc-5cb4-4b4b-a7d5-f2b972e27b3b 61 fields · synced Jun 20, 2026