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joimax® Needle 18G, Quincke, graduated
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref JMSN18XG
by Joimax GmbH
Identity
- Trade Name
- joimax® Needle 18G, Quincke, graduated EUDAMEDN/A FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- joimax® Needle 18G, Quincke, graduated EUDAMEDFDA UDIjoimax® Needle 18G, Quincke EUDAMED
- Model / Reference
- JMSN18XG EUDAMEDFDA UDI
- Description
- joimax® Needle 18G, Quincke, graduated FDA UDI
Identifiers
- Catalog Number
- JMSN18XG FDA UDI
- Primary DI / UDI-DI
- 04250337103394 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337103394 EUDAMED42503371ACNENEE7V EUDAMED
- Direct Marketing DI
- 04250337103394 EUDAMED
- FDA Product Code
- GAA FDA UDI
- EMDN Code
- A019099 NEEDLES FOR OTHER PROCEDURES - OTHER EUDAMED
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
joimax® Needle 18G, Quincke, graduated by Joimax GmbH — 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-04250337103394 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337103394 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (3)
- EUDAMED 00e78d62-fb46-4531-9be7-266ba249c5c8 61 fields · synced Jul 9, 2026
- FDA UDI ab8b6868-c2bd-4c64-b46f-a1f147491dc9 36 fields · synced May 30, 2026
- EUDAMED 7b49f85b-cc8e-4682-811a-3329e73e969a 61 fields · synced Jun 18, 2026