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joimax® Guide Wire super elastic, nonsterile
EUDAMEDFDA UDIClass I (EU MDR)
Ref TGWS50018Ref TGWS40007Ref TGWS30008
by Joimax GmbH
Identity
- Trade Name
- joimax® Guide Wire super elastic, nonsterile EUDAMEDjoimax® Guide Wire, super elastic, unsterile EUDAMEDguide wire FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Device Name
- joimax® Guide Wire super elastic, nonsterile EUDAMEDFDA UDIjoimax® Guide Wire, super elastic, unsterile EUDAMEDFDA UDIGuide Wire with marker, straight, non-sterile EUDAMED
- Model / Reference
- TGWS50018 EUDAMEDFDA UDITGWS40007 EUDAMEDFDA UDITGWS30008 EUDAMEDFDA UDI
- Description
- joimax® Guide Wire super elastic, nonsterile FDA UDIjoimax® Guide Wire, super elastic, unsterile FDA UDI
Identifiers
- Catalog Number
- TGWS50018 FDA UDITGWS40007 FDA UDITGWS30008 FDA UDI
- Primary DI / UDI-DI
- 04250337114154 EUDAMEDFDA UDI04250337101376 EUDAMEDFDA UDI04250337112945 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337114154 EUDAMEDB-04250337101376 EUDAMEDB-04250337112945 EUDAMED42503371GUWIGUWPV EUDAMED
- Direct Marketing DI
- 04250337101376 EUDAMED04250337112945 EUDAMED04250337114154 EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic bone wire FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMED
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMEDAustria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMEDEUDAMED
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
joimax® Guide Wire super elastic, nonsterile by Joimax GmbH — Class I — 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-04250337114154 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337114154 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (9)
- EUDAMED e43bf5f3-9c48-4487-b7fb-a990b4a1baf8 61 fields · synced Sep 17, 2026
- EUDAMED 2f2f6820-fdbf-4cc1-8ad8-044764068995 61 fields · synced May 18, 2026
- EUDAMED 286425df-959b-4999-a8f4-81e52a437174 61 fields · synced May 19, 2026
- FDA UDI 567a4902-7523-4fb5-bb0c-923be9e241ba 36 fields · synced May 30, 2026
- FDA UDI 2c03e367-c2fc-4a07-9ef3-c8955792319d 36 fields · synced May 30, 2026
- FDA UDI 0c02c779-2b2d-46ca-a2e0-580cb5043bc4 36 fields · synced May 30, 2026
- EUDAMED c59a5857-2d35-4788-b7cf-ddcb5b7e1107 61 fields · synced Jun 14, 2026
- EUDAMED 1ac0835e-9404-4bb0-b79c-800a04f58c67 61 fields · synced Jun 20, 2026
- EUDAMED ed24ec70-45d3-4574-8669-49c8ad012e39 61 fields · synced Jul 26, 2026