Identity
- Trade Name
- iGrapher EUDAMED
- Device Name
- Photogrammetry Camera EUDAMED
- Model / Reference
- iGrapher EUDAMEDTF-IG-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974721259266 EUDAMED
- Basic UDI-DI
- 697472125IG001CT EUDAMED
- EMDN Code
- Z119003 BIOIMAGING PHOTOGRAPHY INSTRUMENTS 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
iGrapher by Ningbo Runyes Medical Instrument Co., Ltd. — 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 | 697472125IG001CT | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Runyes Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000014741
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED cf650690-5b06-4e74-9169-261ba4784d74 61 fields · synced Oct 6, 2026