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TD-01 - MAKO - Class IIa - Reamers and Burs
EUDAMEDClass IIa (EU MDR)
Ref 290651Model 08858251002221S4
Identity
- Device Name
- TD-01 - MAKO - Class IIa - Reamers and Burs EUDAMED
- Model / Reference
- 08858251002221S4 EUDAMED290651 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613327595543 EUDAMED
- Basic UDI-DI
- 08858251002221S4 EUDAMED
- Direct Marketing DI
- 07613327595543 EUDAMED
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Category: Acetabular orthopaedic reamer
TD-01 - MAKO - Class IIa - Reamers and Burs by MAKO Surgical Corp. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Acetabular orthopaedic reamer.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08858251002221S4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- MAKO Surgical Corp.
- EUDAMED SRN
- US-MF-000000703
- Authorised Representative
- Stryker European Operations Limited IE-AR-000000092
Sources (1)
- EUDAMED 10d8e148-763d-485f-89fc-d1a2ae3c08c7 61 fields · synced Jun 19, 2026