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Revision Instrument Inner Part
EUDAMEDFDA UDIClass I (EU MDR)
Ref JMPS1053R
by Joimax GmbH
Identity
- Trade Name
- Revision Instrument Inner Part EUDAMEDauditing instrument FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Revision Instrument Inner Part EUDAMEDFDA UDI
- Model / Reference
- JMPS1053R EUDAMEDFDA UDI
- Description
- Revision Instrument Inner Part FDA UDI
Identifiers
- Catalog Number
- JMPS1053R FDA UDI
- Primary DI / UDI-DI
- 04250337110552 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337110552 EUDAMED42503371INSRREVNU EUDAMED
- Direct Marketing DI
- 04250337110552 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMED
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany 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
Revision Instrument Inner Part 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-04250337110552 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337110552 | 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 (3)
- EUDAMED 81a45aa0-10e1-48a0-8ed0-8b2af823b8dc 61 fields · synced Jul 12, 2026
- FDA UDI b6fd1aa2-3012-4690-acd0-e9aecbc1a8a4 35 fields · synced May 30, 2026
- EUDAMED 5804125f-34cc-4a4d-aa3b-17f2cbe72856 61 fields · synced Jul 12, 2026