Identity
- Device Name
- Gripper EUDAMED
- Model / Reference
- ME-GR1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05430001422061 EUDAMED
- Basic UDI-DI
- B-05430001422061 EUDAMED
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Category: Joint prosthesis implantation kit, single-use
Gripper by MedEnvision bv — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-05430001422061 | Class I | Active |
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Manufacturer
- Manufacturer
- MedEnvision bv
- EUDAMED SRN
- BE-MF-000000329
Sources (1)
- EUDAMED fa8dda44-f869-46a6-ae0d-63f1a0676b8b 61 fields · synced Aug 4, 2026