Identity
- Trade Name
- Smart Bulb EUDAMEDFDA UDI
- Generic Name
- Surgical irrigation tubing set, single-use FDA UDI
- Device Name
- Smart Bulb EUDAMEDSmart Bulb is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy, and helps to maintain a clear visual field by displacing blood, stone fragments, and cellular debris. Smart Bulb is designed for controlled irrigation through an endoscope or accessory during urological procedures. FDA UDI
- Model / Reference
- URO 037 EUDAMED1 FDA UDI
- Description
- Smart Bulb is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy, and helps to maintain a clear visual field by displacing blood, stone fragments, and cellular debris. Smart Bulb is designed for controlled irrigation through an endoscope or accessory during urological procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06009900408330 EUDAMEDFDA UDI
- Basic UDI-DI
- 60099004083URO0373F EUDAMED
- FDA Product Code
- FFY FDA UDI
- EMDN Code
- Z12019007 IRRIGATORS EUDAMED
- GMDN Term
- Surgical irrigation tubing set, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Smart Bulb by Wismed (PTY) Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 60099004083URO0373F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wismed (PTY) Ltd
- EUDAMED SRN
- ZA-MF-000035555
- Authorised Representative
- TNMC Devices Llc HR-AR-000019582
Sources (2)
- EUDAMED e819976d-652c-415a-aeaa-7e3bfd8a4e42 61 fields · synced Jul 10, 2026
- FDA UDI 79817b6c-aa80-4fd5-9483-35fa54897b9a 35 fields · synced May 29, 2026