Diamond Abrasor, Ball Tip
EUDAMEDFDA UDIClass IIa (EU MDR)
by Joimax GmbH
Identity
- Trade Name
- Diamond Abrasor, Ball Tip EUDAMEDDiamon Abrasor FDA UDI
- Generic Name
- Arthroscopic shaver system, electrically-powered FDA UDI
- Device Name
- Diamond Abrasor, Ball Tip EUDAMEDFDA UDIBarrel Cutter, Barrel Tip, with distal protection EUDAMED
- Model / Reference
- JSBDA243029 EUDAMEDFDA UDI
- Description
- Diamond Abrasor, Ball Tip FDA UDI
Identifiers
- Catalog Number
- JSBDA243029 FDA UDI
- Primary DI / UDI-DI
- 04250337108153 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337108153 EUDAMED42503371DEFLRESAK EUDAMED
- Direct Marketing DI
- 04250337108153 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- Z12130585 MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Arthroscopic shaver system, electrically-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Poland EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
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
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Spinal shaver system blade
Diamond Abrasor, Ball Tip by Joimax GmbH — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250337108153 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337108153 | 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 a8f08ae2-e20a-4fb5-bddc-112acca9b040 61 fields · synced Jul 22, 2026
- FDA UDI 9aa14c93-f201-49be-89f2-dbeed68a439a 36 fields · synced May 30, 2026
- EUDAMED a5796479-c139-4656-ba3c-2db4518e8eaf 61 fields · synced Jun 19, 2026