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MyLab 9 eHD
EUDAMEDClass IIa (EU MDR)
Ref 100644030Model 6440Ref 100660000Model 66xx
Identity
- Trade Name
- MyLab 9 eHD EUDAMEDMyLabA EUDAMED
- Model / Reference
- 6440 EUDAMED100644030 EUDAMED66xx EUDAMED100660000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056304454157 EUDAMED08056304454645 EUDAMED
- Basic UDI-DI
- B-08056304454157 EUDAMED805630445ESA.US0000008.YG EUDAMED
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
MyLab 9 eHD by Esaote S.p.A. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08056304454157 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08056304454157 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (2)
- EUDAMED 456850eb-04fb-48de-9c7c-9bfd468360f6 61 fields · synced Aug 3, 2026
- EUDAMED f0eb7c29-6517-4be0-b0a0-efaf011d5584 61 fields · synced Jul 31, 2026