Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)
by Jiangsu Micsafe Medical Technology Co., Ltd
510(k) K181426Ref ER03CSH, ER60EMH, ER30CM, ER20CST, ER10CST, ER60CM, ER03CS, ER10CMT, ER01CM, ER10CSH, ER05CS, ER60ESH, ER03CMT, ER20CM, ER60CSH, ER60EM, ER03CST, ER60CS, ER05CM, ER10CM, ER05CMT, ER60EMT, ER30CSH, ER30CS, ER20CMT, ER01CMT, ER06CMT, ER30CST, ER20CMH, ER01CSH, ER10CS, ER60ESModel 3ml Rubber Piston, Eccentric 60ml Silicone O-ring, 30ml Silicone O-ring, Opacus 20ml Rubber Piston, Opacus 10ml Rubber Piston, Centric 60ml Silicone O-ring, Opacus 10ml Silicone O-ring, 1ml Silicone O-ring, 10ml Rubber Piston, 5ml Rubber Piston, Eccentric 60ml Rubber Piston, Opacus 3ml Silicone O-ring, 20ml Silicone O-ring, Centric 60ml Rubber Piston, Opacus 3ml Rubber Piston, 5ml Silicone O-ring, 10ml Silicone O-ring, Opacus 5ml Silicone O-ring, Opacus 60ml Silicone O-ring, 30ml Rubber Piston, Opacus 20ml Silicone O-ring, Opacus 1ml Silicone O-ring, Opacus 30ml Rubber Piston, Centric 20ml Silicone O-ring, 1ml Rubber Piston
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-16971911292451 | Date14 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number06971911292195 | Date31 May 2023 | StatusListed |
| United States | FDA 510(k)SESE 510(k) | NumberK181426 | Date11 Oct 2018 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Enteral Syringe EUDAMEDmicsafe GUDID
- Generic Name
- ENFit oral/enteral syringe, single-useGeneral-purpose syringe, single-use
- Model / Reference
- 3ml Rubber Piston EUDAMEDER03CSH EUDAMEDEccentric 60ml Silicone O-ring EUDAMEDER60EMH EUDAMED30ml Silicone O-ring EUDAMEDER30CM EUDAMEDOpacus 20ml Rubber Piston EUDAMEDER20CST EUDAMEDOpacus 10ml Rubber Piston EUDAMEDER10CST EUDAMEDCentric 60ml Silicone O-ring EUDAMEDER60CM EUDAMEDER03CS EUDAMEDOpacus 10ml Silicone O-ring EUDAMEDER10CMT EUDAMED1ml Silicone O-ring EUDAMEDER01CM EUDAMED10ml Rubber Piston EUDAMEDER10CSH EUDAMED5ml Rubber Piston EUDAMEDER05CS EUDAMEDEccentric 60ml Rubber Piston EUDAMEDER60ESH EUDAMEDOpacus 3ml Silicone O-ring EUDAMEDER03CMT EUDAMED20ml Silicone O-ring EUDAMEDER20CM EUDAMEDCentric 60ml Rubber Piston EUDAMEDER60CSH EUDAMEDER60EM EUDAMEDOpacus 3ml Rubber Piston EUDAMEDER03CST EUDAMEDER60CS EUDAMED5ml Silicone O-ring EUDAMEDER05CM EUDAMED10ml Silicone O-ring EUDAMEDER10CM EUDAMEDOpacus 5ml Silicone O-ring EUDAMEDER05CMT EUDAMEDOpacus 60ml Silicone O-ring EUDAMEDER60EMT EUDAMED30ml Rubber Piston EUDAMEDER30CSH EUDAMEDER30CS EUDAMEDOpacus 20ml Silicone O-ring EUDAMEDER20CMT EUDAMEDOpacus 1ml Silicone O-ring EUDAMEDER01CMT EUDAMEDER06CMT EUDAMEDOpacus 30ml Rubber Piston EUDAMEDER30CST EUDAMEDCentric 20ml Silicone O-ring EUDAMEDER20CMH EUDAMED1ml Rubber Piston EUDAMEDER01CSH EUDAMEDER10CS EUDAMEDER60ES EUDAMED1 GUDID
- FDA applicant
- Jiangsu Micsafe Medical Technology Co., Ltd.
- Primary DI / UDI-DI
- 06971911292195, 06971911292133, 06971911292089, 06971911292003, 16971911292451, 16971911292178, 36971911292134, 06971911292317, 16971911292307, 06971911292232, 26971911292038, 06971911292386, 16971911292475, 06971911292164, 26971911292366, 16971911292055, 26971911292243, 16971911292079, 26971911292281, 36971911292226, 16971911292109, 26971911292045, 26971911292373, 06971911292423, 16971911292130, 06971911292225, 16971911292222, 06971911292478, 26971911292120, 16971911292390, 26971911292359, 26971911292410, 26971911292328, 26971911292151, 16971911292192, 26971911292106, 16971911292499, 26971911292304, 26971911290157, 06971911292157, 26971911292069, 06971911292010, 06971911290153, 06971911292096, 06971911292126, 06971911292065
- Basic UDI-DI
- B-16971911292451, B-16971911292178, B-36971911292134, B-06971911292317, B-16971911292307, B-06971911292232, B-26971911292038, B-06971911292386, B-06971911292089, B-16971911292475, B-06971911292003, B-06971911292164, B-26971911292366, B-16971911292055, B-26971911292243, B-16971911292079, B-26971911292281, B-36971911292226, B-16971911292109, B-06971911292133, B-26971911292045, B-26971911292373, B-06971911292423, B-16971911292130, B-06971911292195, B-06971911292225, B-16971911292222, B-06971911292478, B-26971911292120, B-16971911292390, B-26971911292359, B-26971911292410, B-26971911292328, B-26971911292151, B-16971911292192, B-26971911292106, B-16971911292499, B-26971911292304, B-26971911290157, B-06971911292157, B-26971911292069
- 510(k) Number
- FDA Product Code
- PNR, FMI, MEG, FMF
- EMDN Code
- A020108 Enteral feeding syringes
- GMDN Term
- ENFit oral/enteral syringe, single-useGeneral-purpose syringe, single-use
- Device Class
- Class I EUDAMEDClass II 510(k)GUDID
- Regulation
- 21 CFR Part 876.5980 510(k)GUDID880.5570 GUDID880.5860 GUDID
- EU market of registration
- Germany
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | 510(k) | GUDID |
|---|---|---|---|
| Model / Reference | 3ml Rubber Piston ER03CSH Eccentric 60ml Silicone O-ring ER60EMH 30ml Silicone O-ring ER30CM Opacus 20ml Rubber Piston ER20CST Opacus 10ml Rubber Piston ER10CST Centric 60ml Silicone O-ring ER60CM ER03CS Opacus 10ml Silicone O-ring ER10CMT 1ml Silicone O-ring ER01CM 10ml Rubber Piston ER10CSH 5ml Rubber Piston ER05CS Eccentric 60ml Rubber Piston ER60ESH Opacus 3ml Silicone O-ring ER03CMT 20ml Silicone O-ring ER20CM Centric 60ml Rubber Piston ER60CSH ER60EM Opacus 3ml Rubber Piston ER03CST ER60CS 5ml Silicone O-ring ER05CM 10ml Silicone O-ring ER10CM Opacus 5ml Silicone O-ring ER05CMT Opacus 60ml Silicone O-ring ER60EMT 30ml Rubber Piston ER30CSH ER30CS Opacus 20ml Silicone O-ring ER20CMT Opacus 1ml Silicone O-ring ER01CMT ER06CMT Opacus 30ml Rubber Piston ER30CST Centric 20ml Silicone O-ring ER20CMH 1ml Rubber Piston ER01CSH ER10CS ER60ES | — | 1 |
| Device Class | Class I | Class II | Class II |
Overview
AI-generated summary, 18 Sep 2026
This device is an Enteral Syringe With Enteral Specific Connectors, designed for the administration of liquids via oral or enteral routes. It includes standard and low-dose tip variants, accommodating volumes from 1 mL to 60 mL for precise medication delivery in clinical settings.
The syringes are intended for single-use and are supplied sterile, ensuring compatibility with enteral feeding tubes and oral administration. They are classified as Class II devices under FDA regulations (876.5980) and comply with the Medical Device Directive (MDD). Sizes are fixed as specified, and storage conditions must maintain sterility until use.
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Properties
Other properties (15)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No