Identity
- Trade Name
- Mini Pillow EUDAMEDFDA UDI
- Generic Name
- Surgical irrigation tubing set, single-use FDA UDI
- Device Name
- Mini Pillow EUDAMEDMini Pillow is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy. Irrigation during endoscopy helps to maintain a clear visual field by displacing blood, stone fragments, and cellular debris. Mini Pillow is designed for controlled irrigation through an endoscope or accessory during urological procedures. FDA UDI
- Model / Reference
- URO 052 EUDAMED1 FDA UDI
- Description
- Mini Pillow is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy. Irrigation during endoscopy helps to maintain a clear visual field by displacing blood, stone fragments, and cellular debris. Mini Pillow is designed for controlled irrigation through an endoscope or accessory during urological procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06009900408439 EUDAMEDFDA UDI
- Basic UDI-DI
- 60099004083URO0523B 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
Category: Endoscopic spray catheter, single-use
Mini Pillow by Wismed (PTY) Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic spray catheter, single-use.
- Spray Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class I
- Measuring Jug 250 — Chaplet International Pvt Ltd · Class I
- IRRIGATION SET SIMPLE WAY — LD Medicare · Class IIa
- Spray Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class I
- RoboClean — Era Endoscopy Srl · Class IIa
- Forceps Jar 30 x 80 — Chaplet International Pvt Ltd · Class I
- Trans Urethral Resection Set (TUR Set) — Poly Medicure Limited · Class IIa
- Measuring Jug 500 — Chaplet International Pvt Ltd · Class I
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 | 60099004083URO0523B | 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 2f3a357f-f66d-4cae-90cc-6df7f31ac7a4 61 fields · synced Jun 17, 2026
- FDA UDI b552ba21-a0be-4198-a8cf-3feae8500cdd 35 fields · synced May 30, 2026