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Multi-Site Attachment Ring

EUDAMEDFDA UDI

Class I (EU MDR)

Ref MARe-SF

by Sentec AG

Identity

Trade Name
Multi-Site Attachment Ring EUDAMED
Multi-Site Attachment Ring for fragile/sensitive skin FDA UDI
Generic Name
Pulse Co-oximeter probe, reusable FDA UDI
Device Name
Multi-Site Attachment Ring EUDAMED
Single use sensor application ring, recommended for adult, pediatric and neonatal patients with sensitive/fragile skin FDA UDI
Model / Reference
MARe-SF EUDAMEDFDA UDI
Description
Single use sensor application ring, recommended for adult, pediatric and neonatal patients with sensitive/fragile skin FDA UDI

Identifiers

Primary DI / UDI-DI
07640121880803 EUDAMEDFDA UDI
Basic UDI-DI
764012188MARJD EUDAMED
510(k) Number
K041548 FDA UDI
K071672 FDA UDI
K101690 FDA UDI
K151329 FDA UDI
FDA Product Code
LPP FDA UDI
LKD FDA UDI
KLK FDA UDI
DQA FDA UDI
DPZ FDA UDI
EMDN Code
Z1203020405 TRANSCUTANEOUS PO2/PCO2 MONITORS EUDAMED
GMDN Term
Pulse Co-oximeter probe, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
868.2500 FDA UDI
868.2480 FDA UDI
870.2700 FDA UDI
870.2710 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Multi-Site Attachment Ring by SenTec AG — 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
Sentec AG
EUDAMED SRN
CH-MF-000008058
Authorised Representative
Sentec GmbH DE-AR-000007618

Sources (2)

  • EUDAMED 06030358-eec1-48c0-85e3-da0332ff66d2 61 fields · synced Jun 17, 2026
  • FDA UDI c861fb29-fe67-4906-8a0f-d565509ea28d 35 fields · synced May 29, 2026