Identity
- Trade Name
- Trackfinder Bulb Irrigator EUDAMEDTrackfinder FDA UDI
- Generic Name
- Surgical irrigation tubing set, single-use FDA UDI
- Device Name
- TRACKFINDER BULB IRRIGATOR EUDAMEDTrackfinder Bladder Evacuator FDA UDI
- Model / Reference
- TF EUDAMEDBladder Irrigation FDA UDI
- Description
- Trackfinder Bladder Evacuator FDA UDI
Identifiers
- Catalog Number
- TF FDA UDI
- Primary DI / UDI-DI
- 00812261014401 EUDAMEDFDA UDI
- Basic UDI-DI
- 081226101TBI026QL EUDAMED
- Direct Marketing DI
- 00812261014401 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
- Spain 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Trackfinder Bulb Irrigator by Allwin Medical Devices, Inc. — 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 | 081226101TBI026QL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Allwin Medical Devices, Inc
- EUDAMED SRN
- US-MF-000011349
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED dba417d2-eb00-4466-86bd-828c30d3d375 61 fields · synced Jun 18, 2026
- FDA UDI 531ebfcb-38a5-4ef3-9027-c1ccf27e0f4d 35 fields · synced May 30, 2026
- EUDAMED 732ca74d-f248-4de6-aa9c-145737370cda 61 fields · synced Jun 11, 2026