Identity
- Trade Name
- Staysite Adhesive EUDAMEDFDA UDI
- Generic Name
- Transcutaneous blood gas monitoring system FDA UDI
- Device Name
- Staysite Adhesive EUDAMEDThe Staysite Adhesive (SA-MAR), is an optional, single-use adhesive which is indicated for use with Multi-Site Attachment Rings, models MAR-MI and MAR-SF if more secure attachment is required. FDA UDI
- Model / Reference
- SA-MAR EUDAMEDFDA UDI
- Description
- The Staysite Adhesive (SA-MAR), is an optional, single-use adhesive which is indicated for use with Multi-Site Attachment Rings, models MAR-MI and MAR-SF if more secure attachment is required. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640121880568 EUDAMEDFDA UDI
- Basic UDI-DI
- 764012188SA-MAR6E EUDAMED
- FDA Product Code
- DPZ FDA UDIDQA FDA UDIKLK FDA UDILKD FDA UDILPP 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
- 870.2710 FDA UDI870.2700 FDA UDI868.2500 FDA UDI868.2480 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
Staysite Adhesive 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 | 764012188SA-MAR6E | 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 (2)
- EUDAMED 0e176327-ac45-401a-b2b4-76012b9603c5 61 fields · synced May 30, 2026
- FDA UDI 6cad696c-2261-416e-a80b-6ea996415130 34 fields · synced May 30, 2026