Identity
- Trade Name
- APOTECA FDA UDI
- Generic Name
- Pharmaceutical fluid-dispensing system FDA UDI
- Model / Reference
- APOTECAchemo FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060304050182 FDA UDI
- FDA Product Code
- NEP FDA UDI
- GMDN Term
- Pharmaceutical fluid-dispensing system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pharmaceutical fluid-dispensing system
Apoteca by Aea Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pharmaceutical fluid-dispensing system.
- Mixing Tips — Gc America Inc. · Class II
- DianaTM Automated Drug Compounding System — ICU MEDICAL, INC. · Class II
- Diana Peristaltic Pump Module, Refurbished — ICU MEDICAL, INC. · Class II
- COE® Adhesive — Gc America Inc. · Class II
- MULTI-AD® — B. BRAUN MEDICAL INC. · Class I
- Mixing Tips — Gc America Inc. · Class II
- Mixing Tips — Gc America Inc. · Class II
- Mixing Tips — Gc America Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aea Srl
Sources (1)
- FDA UDI 26862e67-53db-454c-9d99-e5bfc378096e 32 fields · synced Jun 8, 2026