Identity
- Trade Name
- 0155 Signal Converter Package FDA UDI
- Generic Name
- Noninvasive device battery charger FDA UDI
- Model / Reference
- 115-035637-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904086446 FDA UDI
- 510(k) Number
- K150632 FDA UDI
- FDA Product Code
- MSX FDA UDI
- GMDN Term
- Noninvasive device battery charger FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Noninvasive device battery charger
0155 Signal Converter Package by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Noninvasive device battery charger.
- STARKEY HEARING TECHNOLOGIES — Starkey Laboratories Inc. · Class II
- GN Hearing — Gn Hearing A/S · Class II
- CONNEXX — WS Audiology USA, Inc. · Class II
- Unitron Brand — Sonova AG · Class II
- Beltone — Gn Hearing A/S · Class II
- GN Hearing — Gn Hearing A/S · Class II
- Docking Station — Medela LLC · Class II
- GN Hearing — Gn Hearing A/S · Class II
Cleared under the same submission
K150632 also covers:
- 3-Lead, New Telemetry, AHA, Pinch, 24″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, AHA, Pinch, 36″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, AHA, Snap, 24″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, AHA, Snap, 36″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, Disp, AHA, Snap, 24″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, Disp, IEC, Snap, 24″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, IEC, Pinch, 24″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, IEC, Pinch, 36″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, IEC, Snap, 24″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, New Telemetry, IEC, Snap, 36″ — Shenzhen Mindray Bio-Medical Electronics Co.
- 4-channel Receiving Cabinet Package — Shenzhen Mindray Bio-Medical Electronics Co.
- 5-Lead, New Telemetry, AHA, Pinch, 24″ — Shenzhen Mindray Bio-Medical Electronics Co.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI 41815b19-5825-425f-be4f-866736ecb1c5 34 fields · synced May 31, 2026