Identity
- Device Name
- InkRight EUDAMED
- Model / Reference
- 512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815137022388 EUDAMED
- Basic UDI-DI
- 00815137022388CD 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 | 00815137022388CD | Class I | Active |
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Manufacturer
- Manufacturer
- Beekley Corporation
- EUDAMED SRN
- US-MF-000007055
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 92397273-aacf-43dd-96e4-56edd79ff2b7 61 fields · synced Jun 19, 2026