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SteadyTemp

EUDAMEDFDA UDI

Class I (EU MDR)

Ref SteadyTemp

by SteadySense GmbH

Identity

Trade Name
SteadyTemp EUDAMED
femSense Fertility FDA UDI
Generic Name
Thermometric fertility analyser FDA UDI
Device Name
SteadyTemp EUDAMED
Model / Reference
SteadyTemp EUDAMED
1 FDA UDI

Identifiers

Primary DI / UDI-DI
09120095900021 EUDAMEDFDA UDI
Basic UDI-DI
B-09120095900021 EUDAMED
FDA Product Code
LHD FDA UDI
EMDN Code
V03010199 THERMOMETERS - OTHER EUDAMED
GMDN Term
Thermometric fertility analyser FDA UDI

Classification

Device Class
Class I EUDAMED
U FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
Not 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

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

SteadyTemp by SteadySense GmbH — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SteadySense GmbH
EUDAMED SRN
AT-MF-000003984

Sources (2)

  • EUDAMED e0e33046-2267-4eb7-829f-0584b23b30be 61 fields · synced Jul 22, 2026
  • FDA UDI 963740b8-ae7f-4913-9e6d-8a8723a7bb89 34 fields · synced May 29, 2026