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Sensititre Saline - Tween With Glass Beads
EUDAMEDFDA UDIClass A (EU MDR)
Ref T3491
by Remel, Inc.
Identity
- Trade Name
- SENSITITRE SALINE - TWEEN WITH GLASS BEADS EUDAMEDSensititre Saline- Tween w/ Glass Beads FDA UDI
- Generic Name
- Isotonic saline reagent IVD FDA UDI
- Device Name
- SENSITITRE SALINE - TWEEN WITH GLASS BEADS EUDAMED
- Model / Reference
- T3491 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848838091322 EUDAMEDFDA UDI
- Basic UDI-DI
- 8488380SalTweenGlassB45 EUDAMED
- FDA Product Code
- JTZ FDA UDI
- EMDN Code
- W0104080113 OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...) EUDAMED
- GMDN Term
- Isotonic saline reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.1700 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
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
Sensititre Saline - Tween With Glass Beads by Remel, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8488380SalTweenGlassB45 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Remel, Inc.
- EUDAMED SRN
- US-MF-000044686
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED e6036f69-1e12-4407-bf0f-70433d2a7127 61 fields · synced Jul 26, 2026
- FDA UDI 42b2b11b-59bc-4b14-b4c3-8f79b2099b62 32 fields · synced May 30, 2026