Identity
- Trade Name
- ITS Housing EUDAMED
- Device Name
- Injectate Temperature Sensor Housing EUDAMED
- Model / Reference
- PV4046 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07325710011140 EUDAMED
- Basic UDI-DI
- 73257100111486 EUDAMED
- EMDN Code
- C019004 CARDIOVASCULAR MONITORING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
ITS Housing by Maquet Critical Care AB — 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 | 73257100111486 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maquet Critical Care AB
- EUDAMED SRN
- SE-MF-000001264
Sources (1)
- EUDAMED 017b39d9-571d-460a-9f13-449c4f885586 61 fields · synced Oct 7, 2026