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Dualex Ultra Transducer Protector
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SLGVS25US
Identity
- Trade Name
- Dualex Ultra Transducer Protector EUDAMEDFDA UDI
- Generic Name
- Haemodialysis system transducer protector FDA UDI
- Device Name
- Dualex Ultra Transducer Protector EUDAMED
- Model / Reference
- SLGVS25US EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04054839076572 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04054839076572 EUDAMED
- FDA Product Code
- FIB FDA UDI
- EMDN Code
- F9099 DIALYSIS DEVICES - OTHER EUDAMED
- GMDN Term
- Haemodialysis system transducer protector FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5820 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Dualex Ultra Transducer Protector by Merck Millipore Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04054839076572 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Merck Millipore Ltd
- EUDAMED SRN
- IE-MF-000003997
Sources (2)
- EUDAMED dd740362-e3db-40df-854b-cf725a044f6f 61 fields · synced Jul 29, 2026
- FDA UDI d75df202-3f51-45ee-b6c4-4a27659ccfa4 32 fields · synced May 30, 2026