Identity
- Trade Name
- 1072 Hi Pro 2 EUDAMED
- Device Name
- 1072 HI-PRO 2 Hearing Instrument Programmer EUDAMED
- Model / Reference
- 8-04-14800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315010798 EUDAMED
- Basic UDI-DI
- 5713315NA0002456 EUDAMED
- EMDN Code
- Y214599 HEARING AIDS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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
1072 Hi Pro 2 by Natus Medical Denmark ApS — 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 | 5713315NA0002456 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (1)
- EUDAMED 49a23ab5-4ebd-461d-86d6-5d9b0eff5d71 61 fields · synced Jul 31, 2026