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Arthrex BioXpress
EUDAMEDClass IIa (EU MDR)
Ref ABS-10053-15Ref ABS-10053-10-45Ref ABS-10053-15-45
Identity
- Trade Name
- Arthrex BioXpress EUDAMED
- Device Name
- Graft Delivery Device EUDAMEDGraft Delivery Device Angle Tip EUDAMED
- Model / Reference
- ABS-10053-15 EUDAMEDABS-10053-10-45 EUDAMEDABS-10053-15-45 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20815634020683 EUDAMED20815634020690 EUDAMED10815634020709 EUDAMED
- Basic UDI-DI
- B-20815634020683 EUDAMEDB-20815634020690 EUDAMEDB-10815634020709 EUDAMED
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Arthrex BioXpress by Micromedics, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-20815634020683 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Micromedics, Inc.
- EUDAMED SRN
- US-MF-000018365
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 5d2ff27d-cbf4-4036-8d92-c6a7a470882d 61 fields · synced Jul 26, 2026
- EUDAMED 8b7f8dbd-1968-451a-8548-7152895c9013 61 fields · synced May 19, 2026
- EUDAMED 2d0c4c1b-4481-433f-9369-6bd129e7ea2b 61 fields · synced May 19, 2026