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Multi-Site Attachment Ring
EUDAMEDFDA UDIClass I (EU MDR)
Ref MARe-MIRef MAR-MIRef MARe-SF
by Sentec AG
Identity
- Trade Name
- Multi-Site Attachment Ring EUDAMEDMulti-Site Attachment Ring for mature/intact skin FDA UDI
- Generic Name
- Transcutaneous blood gas monitoring system FDA UDI
- Device Name
- Multi-Site Attachment Ring EUDAMEDSingle use sensor application ring, recommended for adult, pediatric and neonatal patients with mature/intact skin FDA UDI
- Model / Reference
- MARe-MI EUDAMEDFDA UDIMAR-MI EUDAMEDMARe-SF EUDAMED
- Description
- Single use sensor application ring, recommended for adult, pediatric and neonatal patients with mature/intact skin FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640121880797 EUDAMEDFDA UDI17640121880220 EUDAMED17640121880800 EUDAMED
- Basic UDI-DI
- 764012188MARJD EUDAMED
- FDA Product Code
- LPP FDA UDILKD FDA UDIKLK FDA UDIDQA FDA UDIDPZ FDA UDI
- EMDN Code
- Z1203020405 TRANSCUTANEOUS PO2/PCO2 MONITORS EUDAMED
- GMDN Term
- Transcutaneous blood gas monitoring system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2500 FDA UDI868.2480 FDA UDI870.2700 FDA UDI870.2710 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764012188MARJD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sentec AG
- EUDAMED SRN
- CH-MF-000008058
- Authorised Representative
- Sentec GmbH DE-AR-000007618
Sources (4)
- EUDAMED 0501cae6-75fb-48f3-91f2-d20de4e56923 61 fields · synced Aug 3, 2026
- EUDAMED da7b94bd-d667-42bc-9df7-0a76de9f9005 61 fields · synced May 17, 2026
- EUDAMED 87a26b5b-3c9f-4afb-a553-a9f229721bf7 61 fields · synced May 19, 2026
- FDA UDI 9e0f4315-9460-454f-acfe-0612db0778b8 35 fields · synced May 30, 2026