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Dosing Device 50 ml
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ASN-50Ref ASN-50-B
by AEA srl
Identity
- Trade Name
- Dosing Device 50 ml EUDAMEDAPOTECA FDA UDI
- Generic Name
- Hazardous fluid syringe FDA UDI
- Device Name
- Dosing Device EUDAMEDPharmacy compounding dosing device FDA UDI
- Model / Reference
- ASN-50 EUDAMEDFDA UDIASN-50-B EUDAMED
- Description
- Pharmacy compounding dosing device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060304050045 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 EUDAMEDClass 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
Dosing Device 50 ml by Aea Srl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506030405ASN9K | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- AEA srl
- EUDAMED SRN
- IT-MF-000027519
Sources (3)
- EUDAMED c3c131c3-7a10-457c-91fb-75353c5f2cc0 61 fields · synced Jul 12, 2026
- FDA UDI 26f5d0cf-f99a-48e3-b70b-56951b2cd9ba 34 fields · synced May 30, 2026
- EUDAMED e0dd0ec8-9c6a-423c-99e0-df444989170a 61 fields · synced Jul 12, 2026