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Precision Flow® Disposable Patient Circuits and Accessories

EUDAMED

Class IIa (EU MDR)

Ref TA-22

by Vapotherm Inc.

Identity

Device Name
Precision Flow® Disposable Patient Circuits and Accessories EUDAMED
Model / Reference
TA-22 EUDAMED

Identifiers

Primary DI / UDI-DI
00841737100775 EUDAMED
Basic UDI-DI
0841737102441VG EUDAMED
Direct Marketing DI
00841737100775 EUDAMED
EMDN Code
R040201 TRACHEOSTOMY HUMIDIFIERS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Italy 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

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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 ef9371eb-982b-45c8-a973-5f8ad3d6cbfe 61 fields · synced Jul 29, 2026