Ha Pure+ 3px Prl
EUDAMEDFDA UDIClass IIa (EU MDR)
by Signia GmbH
Identity
- Trade Name
- HA PURE+ 3PX PRL EUDAMEDSignia Siemens FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- Signia Siemens HA PURE+ 3PX PRL Hearing Aid FDA UDI
- Model / Reference
- RIC EUDAMED10934193 EUDAMEDHA PURE+ 3PX PRL FDA UDI
- Description
- Signia Siemens HA PURE+ 3PX PRL Hearing Aid FDA UDI
Identifiers
- Catalog Number
- 10934193 FDA UDI
- Primary DI / UDI-DI
- 04056839061695 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056839061695 EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, behind-the-ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Air-conduction hearing aid, receiver-in-canal
Ha Pure+ 3px Prl by Signia GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04056839061695 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Signia GmbH
- EUDAMED SRN
- DE-MF-000017173
Sources (2)
- EUDAMED 607f5f8e-3f1f-4448-86ff-8a4326b1cdba 61 fields · synced Jul 12, 2026
- FDA UDI 999646c6-cdff-43b5-9c63-daa218f4e88f 36 fields · synced May 25, 2026