Identity
- Trade Name
- ULTRAFORMER MPT 4.5 EUDAMED
- Device Name
- ULTRASOUND THERAPY EQUIPMENT EUDAMED
- Model / Reference
- UFMC04501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800016902594 EUDAMED
- Basic UDI-DI
- 8800016902518XR EUDAMED
- EMDN Code
- X0402 EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE FOR LIPOLYSIS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Ultraformer Mpt 4.5 by Classys — Class IIb — 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 | 8800016902518XR | Class IIb | Active |
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Manufacturer
- Manufacturer
- Classys
- EUDAMED SRN
- KR-MF-000010116
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 124825c9-80d8-40cb-a83d-0f9b355398e3 61 fields · synced Sep 18, 2026