Identity
- Trade Name
- HYPO NDL 32G X 1/2"; EUDAMEDEXEL Hypodermic Needle 32G x 1/2" EUDAMEDHYPO NDL 32GX1/2"; SOFT PACK FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Hypodermic Needle EUDAMEDEXEL Hypodermic Needle EUDAMEDHYPO NDL 32GX1/2"; SOFT PACK; TSK3213B, 100/BX 1000/CS, 10CS/CRTN FDA UDI
- Model / Reference
- 26392S EUDAMEDFDA UDI
- Description
- HYPO NDL 32GX1/2"; SOFT PACK; TSK3213B, 100/BX 1000/CS, 10CS/CRTN FDA UDI
Identifiers
- Catalog Number
- 26392S FDA UDI
- Primary DI / UDI-DI
- 00020221663921 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221663921 EUDAMED20221HYPONDL264VZ 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
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Market of Registration
- Netherlands EUDAMEDAustria 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
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
Hypo Ndl 32g X 1/2"; by Exelint International, Co. — 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-00020221663921 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221663921 | 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 (3)
- EUDAMED 4ede939b-1f4a-4e2d-b196-3edce063d15d 61 fields · synced Jul 10, 2026
- FDA UDI b0301ce6-ad35-45c1-8dcc-361986bc7ec2 36 fields · synced May 29, 2026
- EUDAMED 8b4519f0-2f88-4b2c-bde7-c9e610692b7f 61 fields · synced Jul 10, 2026