Identity
- Trade Name
- Malem FDA UDI
- Generic Name
- Bladder-emptying vibratory stimulator FDA UDI
- Device Name
- Queen's Square Bladder Stimulator - Selectable (PC9S) FDA UDI
- Model / Reference
- PC9S FDA UDI
- Description
- Queen's Square Bladder Stimulator - Selectable (PC9S) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060049630144 FDA UDI
- FDA Product Code
- ISA FDA UDI
- GMDN Term
- Bladder-emptying vibratory stimulator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5660 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bladder-emptying vibratory stimulator
Malem by Malem Medical Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bladder-emptying vibratory stimulator.
- Malem — MALEM MEDICAL LIMITED · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Malem Medical Limited
Sources (1)
- FDA UDI a426e6ac-56d5-46da-b4b8-7c1f576f45d7 33 fields · synced May 31, 2026