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Staysite Adhesive

EUDAMEDFDA 510(k)

Class I (EU MDR)

Ref SA-MAR510(k) K151329

by Sentec AG

Identity

Trade Name
Staysite Adhesive EUDAMED
Device Name
Staysite Adhesive EUDAMED
Model / Reference
SA-MAR EUDAMED

Identifiers

Primary DI / UDI-DI
17640121880565 EUDAMED
27640121880562 EUDAMED
Basic UDI-DI
764012188SA-MAR6E EUDAMED
510(k) Number
K151329 FDA 510(k)
FDA Product Code
LKD FDA 510(k)
EMDN Code
Z1203020405 TRANSCUTANEOUS PO2/PCO2 MONITORS EUDAMED

Classification

Device Class
Class I EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.2480 FDA 510(k)
Regulation Number
868.2480 FDA 510(k)
Market of Registration
Germany EUDAMED
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Staysite Adhesive by SenTec AG — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Sentec AG
EUDAMED SRN
CH-MF-000008058
Authorised Representative
Sentec GmbH DE-AR-000007618

Sources (3)

  • EUDAMED 2216e48d-d406-4f1f-9278-ac776afdad06 61 fields · synced Jul 14, 2026
  • EUDAMED 3f59edb4-bdac-42d4-b93f-3f2e652c4aa4 61 fields · synced May 17, 2026
  • FDA 510(k) K151329 24 fields · synced May 18, 2026