Identity
- Device Name
- InkRight EUDAMED
- Model / Reference
- 512S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815137022395 EUDAMED
- Basic UDI-DI
- 00815137022395CA EUDAMED
- Unit of Use DI
- 20815137022313 EUDAMED
- EMDN Code
- Z11030585 RADIOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
InkRight by Beekley Corporation — 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 | 00815137022395CA | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beekley Corporation
- EUDAMED SRN
- US-MF-000007055
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED eaccf2e9-6705-4161-9d69-164c6b76f35e 61 fields · synced Jun 18, 2026