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Sphinx HB710 Head Box
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref HB710Model Sphinx PMU710
Identity
- Trade Name
- Sphinx HB710 Head Box FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Sphinx HB710 Head Box EUDAMEDThe Sphinx HB710 Head Box is part of the Sphinx PMU710 system. FDA UDI
- Model / Reference
- Sphinx PMU710 EUDAMEDHB710 EUDAMEDFDA UDI
- Description
- The Sphinx HB710 Head Box is part of the Sphinx PMU710 system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817111020335 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00817111020335 EUDAMED
- 510(k) Number
- K142774 FDA UDI
- FDA Product Code
- OLZ FDA UDIOLV FDA UDIDQA FDA UDI
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI870.2700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sphinx HB710 Head Box by Neurotronics, LLC — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00817111020335 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Neurotronics, LLC
- EUDAMED SRN
- US-MF-000030839
- Authorised Representative
- NIHON KOHDEN EUROPE GmbH DE-AR-000010740
Sources (2)
- EUDAMED c14a7678-271d-4dc6-9640-1bfd105c5018 61 fields · synced Jun 19, 2026
- FDA UDI 6e82c8d0-7e38-4f1b-ad6a-bf1b50521cf5 34 fields · synced May 30, 2026