Identity
- Trade Name
- SMARTeZ Fluid Transfer Set for Manual Filling with Extension Tube 30 cm EUDAMEDSMARTeZ Fluid Transfer Set FDA UDI
- Generic Name
- Fluid transfer set, general-purpose FDA UDI
- Device Name
- SMARTeZ Fluid Transfer Set EUDAMEDSMARTeZ Fluid Transfer Set (Extension Tube 30cm) FDA UDI
- Model / Reference
- 470110 EUDAMEDFDA UDI
- Description
- SMARTeZ Fluid Transfer Set (Extension Tube 30cm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18859299180110 EUDAMEDFDA UDI
- Basic UDI-DI
- 88592991B012U9 EUDAMED
- FDA Product Code
- KYX FDA UDI
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
- GMDN Term
- Fluid transfer set, general-purpose FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 880.6430 FDA UDI
- Market of Registration
- Sweden 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fluid transfer set, general-purpose
SMARTeZ Fluid Transfer Set by Epic International(thailand) Company Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Epic International(thailand) Company Limited
Sources (2)
- FDA UDI 036b5b8e-fd13-4ac8-911b-dd24a55e00b1 33 fields · synced Jul 23, 2026
- EUDAMED 9babb671-6399-4eff-91cb-78e795061c5a 61 fields · synced Jul 23, 2026