Identity
- Trade Name
- LLD accessory kit EUDAMED
- Device Name
- LLD accessory kit EUDAMED
- Model / Reference
- 518-027 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813132029661 EUDAMED
- Basic UDI-DI
- 081313202BM888NE EUDAMED
- EMDN Code
- C01901903 VESSEL HARVESTING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
LLD accessory kit by Philips Image Guided Therapy Corporation — Class IIa — 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 | 081313202BM888NE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Philips Image Guided Therapy Corporation
- EUDAMED SRN
- US-MF-000018632
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (1)
- EUDAMED 609f4873-2d92-4b7a-a2e6-7c39a8c2604b 61 fields · synced Jul 15, 2026