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HAI-RadX Suite
EUDAMEDClass IIb (EU MDR)
Ref HAI-RadX Suite CTC 2Model Annalise Container
Identity
- Trade Name
- HAI-RadX Suite EUDAMED
- Model / Reference
- Annalise Container EUDAMEDHAI-RadX Suite CTC 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G140HAIRADXSUITECTC20/$$7CTC-2.0.2B EUDAMEDG140HAIRADXSUITECTC20 EUDAMED
- Basic UDI-DI
- ++G140ANNALISECONTAINERR9 EUDAMED
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software 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
HAI-RadX Suite by Harrison-AI Medical Pty Ltd — Class IIb — 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 | ++G140ANNALISECONTAINERR9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Harrison-AI Medical Pty Ltd
- EUDAMED SRN
- AU-MF-000010247
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (2)
- EUDAMED 4b0333c3-221c-4e62-bc99-05cdc835bd47 61 fields · synced Jul 17, 2026
- EUDAMED eca61f4d-207a-4ac0-873a-8157853e24de 61 fields · synced Jul 17, 2026