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EpiFaith Syringe
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref EF-01SLR, EF-02SNR, EF-01SLLModel Luer Slip, Luer Lock, NRFit510(k) K182268Ref EF-01SLR
Identity
- Trade Name
- EpiFaith Syringe EUDAMEDFDA UDI
- Generic Name
- Low-resistance epidural syringe FDA UDI
- Device Name
- EpiFaith Syringe EUDAMEDEpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space FDA UDI
- Model / Reference
- Luer Slip, Luer Lock, NRFit EUDAMEDEF-01SLR, EF-02SNR, EF-01SLL EUDAMEDEF-01SLR EUDAMEDFM-01SLR FDA UDI
- Description
- EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719875599019 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987559901EPSyringeE3 EUDAMEDB-04719875599019 EUDAMED
- 510(k) Number
- K192421 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A020101 LOSS-OF-RESISTANCE SYRINGES EUDAMED
- GMDN Term
- Low-resistance epidural syringe FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Market of Registration
- Netherlands EUDAMEDGreece 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
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
EpiFaith Syringe by Flat Medical Co., Ltd. — Class I — FDA_510K, MDD, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192421 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K182268 | Class I | Active |
| EUDAMED | European Union | CE/MDD | 471987559901EPSyringeE3 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 471987559901EPSyringeE3 | Class I | Active |
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Manufacturer
- Manufacturer
- Flat Medical Co., Ltd.
- EUDAMED SRN
- TW-MF-000002272
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (4)
- EUDAMED 594cb0ed-71fc-4525-9b3a-931a6f65228d 85 fields · synced Jun 18, 2026
- EUDAMED 0aa697c3-5209-4248-90a7-4a1e57b7e256 61 fields · synced May 17, 2026
- FDA UDI 92611675-a725-403f-8918-0bdd37a5261b 36 fields · synced May 29, 2026
- FDA 510(k) K192421 1 fields · synced May 18, 2026