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ZELOSTAT Needle
EUDAMEDClass IIa (EU MDR)
Ref NZ-25S-25-100Model ZELOSTAT Needle 35GRef NZ-35S-04-050Ref NZ-31S-09-100Ref NZ-31S-04-100Ref NZ-34S-09-100
Identity
- Trade Name
- ZELOSTAT Needle EUDAMED
- Device Name
- ZELOSTAT Needle EUDAMED
- Model / Reference
- ZELOSTAT Needle 35G EUDAMEDNZ-25S-25-100 EUDAMEDNZ-35S-04-050 EUDAMEDNZ-31S-09-100 EUDAMEDNZ-31S-04-100 EUDAMEDNZ-34S-09-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582542160047 EUDAMED04582542160108 EUDAMED04582542160061 EUDAMED04582542160054 EUDAMED04582542160085 EUDAMED
- Basic UDI-DI
- 458254216004CB EUDAMED
- EMDN Code
- A01010199 HYPODERMIC NEEDLES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDGermany 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ZELOSTAT Needle by Asti Corporation — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 458254216004CB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Asti Corporation
- EUDAMED SRN
- JP-MF-000007443
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (5)
- EUDAMED a2047acf-dc74-4fe6-b7d9-a985a2ba1db4 61 fields · synced Jul 31, 2026
- EUDAMED f5e501d9-93e6-4914-8e9f-c6b1a2bf0e14 61 fields · synced May 17, 2026
- EUDAMED c3c5a328-9ff6-4f99-99c0-e8dff68c140a 61 fields · synced May 18, 2026
- EUDAMED ac41421f-3064-4ff5-a432-ab53ff9e9354 61 fields · synced May 18, 2026
- EUDAMED d1a031fd-30cd-455a-a232-934fc3f7d5ee 61 fields · synced May 18, 2026