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EndoPAT™ PneumaticPAT™ probe

EUDAMEDFDA UDI

Class I (EU MDR)

Ref AC1600005

by Itamar Medical Ltd.

Identity

Trade Name
EndoPAT™ PneumaticPAT™ probe EUDAMED
12 Pneumatic Endo probes for Endo PAT 2000 FDA UDI
Generic Name
Cardiovascular-risk peripheral arterial tonometry system sensor FDA UDI
Device Name
Pneumatic Endo probe EUDAMED
12 Pneumatic Endo probes FDA UDI
Model / Reference
AC1600005 EUDAMED
12 Pneumatic Endo probes for Endo PAT 2000 FDA UDI
Description
12 Pneumatic Endo probes FDA UDI

Identifiers

Catalog Number
AC1600005 FDA UDI
Primary DI / UDI-DI
07290109225005 EUDAMEDFDA UDI
Basic UDI-DI
729010922AC16000ME EUDAMED
510(k) Number
K032519 FDA UDI
K211557 FDA UDI
FDA Product Code
DQK FDA UDI
EMDN Code
Z12030285 VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES EUDAMED
GMDN Term
Cardiovascular-risk peripheral arterial tonometry system sensor FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

EndoPAT™ PneumaticPAT™ probe by Itamar Medical Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Itamar Medical Ltd.
EUDAMED SRN
IL-MF-000012046
Authorised Representative
Arazy Group GmbH DE-AR-000007685

Sources (2)

  • EUDAMED 3d487c2d-aa9b-4a27-82a8-61846e75ad92 61 fields · synced Jun 18, 2026
  • FDA UDI e2630e40-d13d-4c1e-9445-f4a1562a7944 37 fields · synced May 30, 2026