← Back to catalogue
Exel Securetouch Safety Hypo Ndl 18gx1-1/2"
EUDAMEDClass IIa (EU MDR)
Ref 27420
Identity
- Trade Name
- EXEL SECURETOUCH SAFETY HYPO NDL 18GX1-1/2" EUDAMEDEXEL SecureTouch Safety Hypodermic Needle 18G X 1½” EUDAMED
- Device Name
- Safety Needle EUDAMEDEXEL SecureTouch Safety Hypodermic Needle EUDAMED
- Model / Reference
- 27420 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00020221274202 EUDAMED
- Basic UDI-DI
- B-00020221274202 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 18gx1-1/2" by Exelint International, Co. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hypodermic needle, single-use.
- Monoject — Cardinalhealth · Class II
- Pinpoint GT — Bard Access Systems, Inc. · Class II
- Safety Needle — Jiangsu Micsafe Medical Technology Co., Ltd · Class IIa
- Syringe w/Needle, Non-Toxic, 25G x 1", Luer Lock — Dynarex Corp. · Class II
- Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- EasyTouch — MHC Medical Products · Class II
- STERiJECT TM — TSK LABORATORY, JAPAN · Class II
- Comfort EZ Pro — S.D.I. USA, INC. · Class II
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-00020221274202 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221274202 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Exelint International, Co.
- EUDAMED SRN
- US-MF-000037396
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4d9aa429-2d5d-463e-90ca-7547ae93a6fd 61 fields · synced Oct 6, 2026
- EUDAMED 6b7e673b-041d-43ec-965b-ace7feffe7d5 61 fields · synced Jul 10, 2026