Identity
- Trade Name
- NeuCare Mammo DR HD EUDAMED
- Device Name
- Digital Mammography System EUDAMED
- Model / Reference
- none EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970167440572 EUDAMED
- Basic UDI-DI
- B-06970167440572 EUDAMED
- EMDN Code
- Z11030202 DIGITAL MAMMOGRAPHY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
NeuCare Mammo DR HD by Neusoft Medical Systems Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970167440572 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
- EUDAMED SRN
- CN-MF-000011819
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED cf8d589e-9ff4-4fd6-8ed3-9c3c8e80fdda 61 fields · synced Jun 18, 2026