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MAC Instrument System
EUDAMEDClass I (EU MDR)
Ref GEM2745
by Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.)
Identity
- Trade Name
- MAC Instrument System EUDAMED
- Device Name
- Microvascular Anastomotic COUPLER System EUDAMED
- Model / Reference
- GEM2745 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00844735006629 EUDAMED
- Basic UDI-DI
- 478180000000000000001307M EUDAMED
- EMDN Code
- L1099 MICROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
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
MAC Instrument System by Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.) — Class I — MDR — listed in EUDAMED
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 | 478180000000000000001307M | Class I | Active |
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Manufacturer
- EUDAMED SRN
- US-MF-000034162
- Authorised Representative
- Baxter Deutschland GmbH DE-AR-000010308
Sources (1)
- EUDAMED f41ef825-bbe1-4e30-a993-ea89ddd28418 61 fields · synced Oct 7, 2026