Identity
- Trade Name
- EXEL 2-3mL SYR W/ SAFETY NDL 23GX1" EUDAMEDEXEL Syringes FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- Syringe with safety needle EUDAMEDEXEL 2-3CC SYR W/ SAFETY NDL 23GX1" L-L FDA UDI
- Model / Reference
- 27101 EUDAMEDFDA UDI
- Description
- EXEL 2-3CC SYR W/ SAFETY NDL 23GX1" L-L FDA UDI
Identifiers
- Catalog Number
- 27101 FDA UDI
- Primary DI / UDI-DI
- 00020221271010 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221271010 EUDAMED
- 510(k) Number
- K861153 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
- GMDN Term
- General-purpose syringe, single-use 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
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
No
FDA UDI
Category: Hypodermic needle, single-use
EXEL 2-3mL SYR W/ SAFETY NDL 23GX1" by Exelint International, Co. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-00020221271010 | 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 b02a5475-94c8-471e-9c9a-745303e959a8 61 fields · synced Jun 17, 2026
- FDA UDI 2a11831a-c56d-4182-be34-c5602b42cbb7 35 fields · synced May 30, 2026