Identity
- Trade Name
- EXEL SECURETOUCH SAFETY HYPO NDL 30GX1/2" EUDAMEDEXEL SecureTouch Safety Hypodermic Needle 30G X ½” EUDAMED
- Device Name
- Safety Needle EUDAMEDEXEL SecureTouch Safety Hypodermic Needle EUDAMED
- Model / Reference
- 27437 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00020221274370 EUDAMED
- Basic UDI-DI
- B-00020221274370 EUDAMED20221HYPOSFT2742N EUDAMED
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMEDAustria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Hypodermic needle, single-use
Exel Securetouch Safety Hypo Ndl 30gx1/2" by Exelint International, Co. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hypodermic needle, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00020221274370 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221274370 | Class IIa | Active |
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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 cd91a889-ebdb-4e0e-8273-3a784106021b 61 fields · synced Jul 18, 2026
- EUDAMED ffb672fd-64a0-4968-b425-2c5cbe1b5d83 61 fields · synced Jul 14, 2026