Identity
- Trade Name
- ProSeal Injector (DMA Compatible) EUDAMEDProSeal CSTD FDA UDI
- Generic Name
- Luer/Luer linear connector, single-use FDA UDI
- Device Name
- CSTD and Administration Devices EUDAMEDProSeal Injector (DMA Compatible) FDA UDI
- Model / Reference
- 421010VT EUDAMEDFDA UDI
- Description
- ProSeal Injector (DMA Compatible) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18859299124121 EUDAMEDFDA UDI
- Basic UDI-DI
- 88592991B014UD EUDAMED
- 510(k) Number
- K192075 FDA UDI
- FDA Product Code
- ONB FDA UDI
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
- GMDN Term
- Luer/Luer linear connector, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 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
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
Category: Luer/Luer linear connector, single-use
ProSeal CSTD by Epic International(thailand) Company Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Luer/Luer linear connector, single-use.
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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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Epic International(thailand) Company Limited
Sources (2)
- FDA UDI 6e27c84b-a37b-4312-b169-50ed3355c30c 34 fields · synced Jul 27, 2026
- EUDAMED 4d8a177c-d404-41c7-9338-0cbfc057c62e 61 fields · synced Jul 27, 2026