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Dosing Device 5 ml

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref ASN-05Ref ASN-05-B

by AEA srl

Identity

Trade Name
Dosing Device 5 ml EUDAMED
Dosing device 5ml EUDAMED
APOTECA FDA UDI
Generic Name
Hazardous fluid syringe FDA UDI
Device Name
Dosing Device EUDAMED
Pharmacy compounding dosing device FDA UDI
Model / Reference
ASN-05 EUDAMEDFDA UDI
ASN-05-B EUDAMED
Description
Pharmacy compounding dosing device FDA UDI

Identifiers

Primary DI / UDI-DI
05060304050014 EUDAMEDFDA UDI
Basic UDI-DI
506030405ASN9K EUDAMED
510(k) Number
K132011 FDA UDI
FDA Product Code
FMF FDA UDI
EMDN Code
A020102020101 INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE EUDAMED
GMDN Term
Hazardous fluid syringe FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
880.5860 FDA UDI
Market of Registration
Italy 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

The Dosing Device 5 ml is a precision dosing device designed for accurate and controlled medication administration, particularly in critical care settings where high-potency medications must be administered in small quantities. It features a user-friendly interface, a clear indication of dose accuracy, and a robust sterilization process to ensure patient safety.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
AEA srl
EUDAMED SRN
IT-MF-000027519

Sources (3)

  • EUDAMED 58e6daec-0e71-408c-911c-47d66b27cf16 61 fields · synced Jul 14, 2026
  • FDA UDI 3620f94e-b670-49d2-9789-048f116a6843 34 fields · synced May 30, 2026
  • EUDAMED 421b87ee-957f-40ab-b657-72c80fb54d29 61 fields · synced Jul 14, 2026