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
- EF-02SNR EUDAMEDFM-02SNR 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
- 04719875599026 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04719875599026 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
- Greece 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
EpiFaith Syringe by Flat Medical Co., Ltd. — Class I — 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-04719875599026 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED 6460d19f-f4e4-475c-bf49-67b724f23d08 61 fields · synced May 30, 2026
- FDA UDI b02a71a9-8cb9-457e-ace6-27ba414fa8f3 36 fields · synced May 30, 2026