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SDM Water Protection Cover
EUDAMEDFDA UDIClass I (EU MDR)
Ref SDM_WPC
by Sentec AG
Identity
- Trade Name
- SDM Water Protection Cover EUDAMEDFDA UDI
- Generic Name
- Pulse Co-oximeter probe, reusable FDA UDI
- Device Name
- SDM Water Protection Cover EUDAMEDThis cover will protect the SenTec Digital Monitor (SDM) from dripping water when the device is tilted up to 15° (IPX2). FDA UDI
- Model / Reference
- SDM_WPC EUDAMEDFDA UDI
- Description
- This cover will protect the SenTec Digital Monitor (SDM) from dripping water when the device is tilted up to 15° (IPX2). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640121880889 EUDAMEDFDA UDI
- Basic UDI-DI
- 764012188WPCLE 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
- Pulse Co-oximeter probe, reusable 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SDM Water Protection Cover 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 | 764012188WPCLE | 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 990d8cfd-4424-4570-9b18-89fccc5a875e 61 fields · synced Jun 18, 2026
- FDA UDI 02d30dae-74f3-4fd2-8c32-343a227961cf 34 fields · synced May 30, 2026