Identity
- Trade Name
- Wire cutter EUDAMEDFDA UDI
- Generic Name
- Electromagnetic surgical navigation device tracking system FDA UDI
- Device Name
- Wire cutter EUDAMED
- Model / Reference
- JINTWC EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337117988 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371INNAWCD7 EUDAMED
- Direct Marketing DI
- 04250337117988 EUDAMED
- FDA Product Code
- HXZ FDA UDI
- EMDN Code
- L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Electromagnetic surgical navigation device tracking system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Electromagnetic surgical navigation device tracking system
Wire cutter by Joimax, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI e67f861d-8301-40d8-8f10-6cd0c6b6fd60 32 fields · synced Jun 19, 2026
- EUDAMED 5d755d07-2b60-40f5-9042-eeaecc935f8b 61 fields · synced Jun 19, 2026