Identity
- Trade Name
- EMED Sub-Q Infusion Set EUDAMEDSUB-Q FDA UDI
- Generic Name
- Mechanical infusion pump administration set FDA UDI
- Device Name
- Subcutaneous Infusion Set EUDAMED36" Single SUB-Q set, 9mm needle and 24-gauge w/Dressing FDA UDI
- Model / Reference
- SUB-109-G24 EUDAMEDFDA UDI
- Description
- 36" Single SUB-Q set, 9mm needle and 24-gauge w/Dressing FDA UDI
Identifiers
- Catalog Number
- SUB-109-G24 FDA UDI
- Primary DI / UDI-DI
- 00817708021257 EUDAMED00817708021264 FDA UDI
- Basic UDI-DI
- B-00817708021257 EUDAMED
- FDA Product Code
- FPA FDA UDI
- EMDN Code
- Z12030385 INFUSION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Mechanical infusion pump administration set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- France 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
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
Dimensions & Sizes
- Size
- Needle Gauge — 24 Gauge FDA UDILength — 9 Millimeter FDA UDILength — 91.4 Centimeter FDA UDITotal Volume — 0.34 Milliliter FDA UDI
EMED Sub-Q Infusion Set by EMED Technologies Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00817708021257 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- EMED Technologies Corporation
- EUDAMED SRN
- US-MF-000012148
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED e57cf26b-b458-43f8-9dbf-232ba3a0f837 61 fields · synced Jun 9, 2026
- FDA UDI c2708ba9-9cdc-478d-8364-1b940ac7cde7 38 fields · synced May 29, 2026