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Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1001216
Identity
- Trade Name
- Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’ EUDAMEDFDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Device Name
- Syringe with needle EUDAMEDTandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’ 100/BX, 800/CS FDA UDI
- Model / Reference
- 1001216 EUDAMEDFDA UDI
- Description
- Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’ 100/BX, 800/CS FDA UDI
Identifiers
- Catalog Number
- 1001216 FDA UDI
- Primary DI / UDI-DI
- 00020221012163 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221012163 EUDAMED
- 510(k) Number
- K861153 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS EUDAMED
- GMDN Term
- General-purpose syringe/needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’ by Exelint International, Co. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00020221012163 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Exelint International, Co.
- EUDAMED SRN
- US-MF-000037396
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 71f0038f-c051-49ae-b629-7ca254fec403 61 fields · synced Oct 6, 2026
- FDA UDI 22f83003-25d5-45f7-84e6-bf5de1adae32 36 fields · synced May 30, 2026