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 blade, single-use FDA UDI
- Device Name
- Diamond Abrasor, Ball Tip EUDAMEDFDA UDIBarrel Cutter, Barrel Tip, with distal protection EUDAMED
- Model / Reference
- JSBDA273534 EUDAMEDFDA UDI
- Description
- Diamond Abrasor, Ball Tip FDA UDI
Identifiers
- Catalog Number
- JSBDA273534 FDA UDI
- Primary DI / UDI-DI
- 04250337116417 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337116417 EUDAMED42503371DEFLRESAK EUDAMED
- Direct Marketing DI
- 04250337116417 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- Z12130585 MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Arthroscopic shaver system blade, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Germany 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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Also classified as Spinal shaver system blade.
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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-04250337116417 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337116417 | 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 2dd7f7e5-97ee-4ed9-a131-b5ab124eaac9 61 fields · synced Jul 15, 2026
- FDA UDI 4edf970f-e58a-459d-8512-424e30ceb5f4 36 fields · synced May 30, 2026
- EUDAMED fd4ba5ba-b020-4947-ad7f-7e9121b5820b 61 fields · synced Jun 18, 2026