Identity
- Trade Name
- EXEL HYPO NDL 28G X 3/4" EUDAMEDEXEL Hypodermic Needle 28G x 3/4” T.W. EUDAMED
- Device Name
- Hypodermic Needle EUDAMEDEXEL Hypodermic Needle EUDAMED
- Model / Reference
- 26448 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00020221264487 EUDAMED
- Basic UDI-DI
- B-00020221264487 EUDAMED20221HYPONDL264VZ EUDAMED
- EMDN Code
- A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O 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
Exel Hypo Ndl 28g X 3/4" by Exelint International, Co. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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-00020221264487 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221264487 | 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 54249759-7cdb-4b2b-ae8a-d187b43e548c 61 fields · synced Jul 22, 2026
- EUDAMED 1c56f41d-4855-4944-8696-8348798a90fd 61 fields · synced Jul 22, 2026