Identity
- Trade Name
- DANA 3cc Syringe FDA UDI
- Generic Name
- Ambulatory insulin infusion pump reservoir FDA UDI
- Device Name
- DANA 3cc Syringe EUDAMEDDANA 3cc Syringe is an insulin reservoir for using insulin pump. It is installed into the SOOIL's insulin pump and connected to an infusion set in order to deliver insulin to the patients. FDA UDI
- Model / Reference
- SD-300 EUDAMEDDANA 3cc Syringe FDA UDI
- Description
- DANA 3cc Syringe is an insulin reservoir for using insulin pump. It is installed into the SOOIL's insulin pump and connected to an infusion set in order to deliver insulin to the patients. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809220580765 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809220580765 EUDAMED88092205843507Y EUDAMED
- 510(k) Number
- K071418 FDA UDI
- FDA Product Code
- MRZ FDA UDI
- EMDN Code
- Z12030385 INFUSION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Ambulatory insulin infusion pump reservoir FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Market of Registration
- Germany 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
Dimensions & Sizes
- Size
- Weight — 7.4 Gram FDA UDIOuter Diameter — 14.4 Millimeter FDA UDINeedle Gauge — 26 Gauge FDA UDI
DANA 3cc Syringe by Sooil Development Co., Ltd. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08809220580765 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809220580765 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SOOIL Development Co., Ltd.
- EUDAMED SRN
- KR-MF-000008627
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (3)
- EUDAMED 9c2209ce-73bd-4710-81bc-c1ef77541213 61 fields · synced Jul 9, 2026
- EUDAMED 1de0b7ec-c96f-4ed5-9a1f-2a1f63386316 61 fields · synced May 17, 2026
- FDA UDI b84b5142-c168-4cf7-99c3-17e2402f5bdb 35 fields · synced May 30, 2026