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Securegard
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 5348EModel 3 ml 23Gx1"
by SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag
Identity
- Trade Name
- Securegard EUDAMEDFDA UDI
- Generic Name
- Metered-delivery hypodermic syringe/needle FDA UDI
- Device Name
- Securegard 3 ml 23Gx1" syringe EUDAMEDFDA UDISecuregard 5 ml 23Gx1" syringe FDA UDI
- Model / Reference
- 3 ml 23Gx1" EUDAMED5348E EUDAMED1.0 FDA UDI
- Description
- Securegard 5 ml 23Gx1" syringe FDA UDISecuregard 3 ml 23Gx1" syringe FDA UDI
Identifiers
- Catalog Number
- 5158E FDA UDI5348E FDA UDI
- Primary DI / UDI-DI
- 05999039508425 EUDAMEDFDA UDI05999039508579 FDA UDI
- Basic UDI-DI
- B-05999039508425 EUDAMED
- 510(k) Number
- K993609 FDA UDI
- FDA Product Code
- MEG FDA UDI
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
- GMDN Term
- Metered-delivery hypodermic syringe/needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Market of Registration
- Hungary 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Metered-delivery hypodermic syringe/needle
Securegard by SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag — Class II — MDD, FDA UDI — listed in FDA…
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Also classified as Metered-delivery hypodermic syringe/needle.
- BD Integra — BECTON DICKINSON AND COMPANY · Class II
- Magellan — Cardinal Health 200, LLC · Class II
- Magellan — Cardinal Health 200, LLC · Class II
- VanishPoint® — Retractable Technologies, Inc. · Class II
- Suresafe 1ml Syringe — DMC MEDICAL LIMITED · Class II
- BD Integra — BECTON DICKINSON AND COMPANY · Class II
- VanishPoint® — Retractable Technologies, Inc. · Class II
- Safety Syringe w/Needle — Dynarex Corp. · Class II
Cleared under the same submission
K993609 also covers:
- Securegard — SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag
- Securegard — SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag
- Securegard — SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag
- Securegard — SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag
- Securegard — SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag
- Securegard — SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag
- Securegard — SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag
- Securegard — SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag
- Securegard — SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag
- Securegard — SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag
- Securegard — SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag
- Securegard — SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (3)
- FDA UDI f8cc2cc1-cd99-4a04-a867-246866961705 35 fields · synced Jul 9, 2026
- FDA UDI a0efa492-c6ab-4e0b-a36a-26e58b9acc0f 35 fields · synced May 29, 2026
- EUDAMED 577724f0-9542-40cc-9bda-4f38307ac5c8 61 fields · synced Jul 9, 2026