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Cardinal Health
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 8881511310Model 1mL 30Gx5/16"(0.3x8mm)
Identity
- Trade Name
- Cardinal Health EUDAMEDFDA UDI
- Generic Name
- Insulin syringe/needle, safety FDA UDI
- Device Name
- Disposable Safelock Insulin Syringes EUDAMEDSafety disposable insulin syringe is intended to inject U-100 insulin into the human body and aid in the prevention of accidental needle stick injuries. FDA UDI
- Model / Reference
- 1mL 30Gx5/16"(0.3x8mm) EUDAMED8881511310 EUDAMED1ml 30Gx5/16" FDA UDI
- Description
- Safety disposable insulin syringe is intended to inject U-100 insulin into the human body and aid in the prevention of accidental needle stick injuries. FDA UDI
Identifiers
- Catalog Number
- 8881511310 FDA UDI
- Primary DI / UDI-DI
- 06971564467520 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971564467520 EUDAMED
- 510(k) Number
- K150758 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A0201060301 INSULIN SYRINGES WITH SAFETY SYSTEMS AND FIXED NEEDLES, SINGLE-USE EUDAMED
- GMDN Term
- Insulin syringe/needle, safety FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cardinal Health by Jiangsu Caina Medical Co., Ltd. — 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-06971564467520 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Caina Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011217
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 25599666-7122-4cdb-8df2-2493a899a2a3 61 fields · synced Jul 28, 2026
- FDA UDI afe9ce8f-83f5-4879-8676-a93d93bdc6a5 35 fields · synced May 30, 2026