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Precision Flow® Disposable Patient Circuits and Accessories
EUDAMEDClass IIa (EU MDR)
Ref PF-STAND-D
Identity
- Device Name
- Precision Flow® Disposable Patient Circuits and Accessories EUDAMED
- Model / Reference
- PF-STAND-D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841737105855 EUDAMED
- Basic UDI-DI
- 0841737102441VG EUDAMED
- EMDN Code
- Z12030399 INFUSION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Precision Flow® Disposable Patient Circuits and Accessories by Vapotherm 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 | 0841737102441VG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Vapotherm Inc.
- EUDAMED SRN
- US-MF-000006231
- Authorised Representative
- AJW Technology Consulting GmbH DE-AR-000004999
Sources (1)
- EUDAMED b5b596e6-1169-4108-b264-28d9b0677685 61 fields · synced Jul 21, 2026