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TD-01 - MAKO - Class I (r) - Tracking-Metal
EUDAMEDClass I (EU MDR)
Ref 190661Model 08858251002225SC
Identity
- Device Name
- TD-01 - MAKO - Class I (r) - Tracking-Metal EUDAMED
- Model / Reference
- 08858251002225SC EUDAMED190661 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613327595482 EUDAMED
- Basic UDI-DI
- 08858251002225SC EUDAMED
- Direct Marketing DI
- 07613327595482 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I 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
TD-01 - MAKO - Class I (r) - Tracking-Metal by MAKO Surgical Corp. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 08858251002225SC | Class I | 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 c44171d1-40b1-4941-86c7-b451b5c3c7f8 61 fields · synced Jul 13, 2026