Identity
- Trade Name
- Dexter EUDAMED
- Device Name
- Bipolar Maryland Dissector EUDAMED
- Model / Reference
- Dexter L6 EUDAMED512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640184840547 EUDAMED
- Basic UDI-DI
- 764018484IN-B1017C EUDAMED
- EMDN Code
- K01020299 ROBOTIC SURGERY INSTRUMENT, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Dexter by Distalmotion SA — Class IIb — 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 | 764018484IN-B1017C | Class IIb | Active |
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Manufacturer
- Manufacturer
- Distalmotion SA
- EUDAMED SRN
- CH-MF-000037226
- Authorised Representative
- Distalmotion Deutschland GmbH DE-AR-000046740
Sources (1)
- EUDAMED 5d31c884-e7b1-4d0f-b57a-2e7b46d386d0 61 fields · synced May 23, 2026