Identity
- Trade Name
- AquaPulse® Irrigation Tubing EUDAMED
- Device Name
- Irrigation Tubing EUDAMED
- Model / Reference
- GAR083 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897106954995 EUDAMED
- Basic UDI-DI
- 489710695GAR073FV EUDAMED
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Tissue morcellation system handpiece, line-powered
AquaPulse® Irrigation Tubing by Ga Health Company Limited — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Tissue morcellation system handpiece, line-powered.
- Aveta Disposable Resecting Device 2.9 mm — Meditrina, Inc. · Class II
- Disposable Guidewire — Alton (Shanghai) Medical Instruments Co., Ltd. · Class I
- Polyp Traps — ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. · Class I
- Guide Wires — Changzhou Health Microport Medical Device Co., Ltd · Class IIa
- Aveta Disposable Resecting Device 3.9 mm — Meditrina, Inc. · Class II
- Disposable Guidewire — Alton (Shanghai) Medical Instruments Co., Ltd. · Class I
- NICO Myriad — NICO Corporation · Class II
- OverStitch™ — Boston Scientific · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202560 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K223171 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 489710695GAR073FV | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GA Health Company Limited
- EUDAMED SRN
- HK-MF-000019784
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 3529df57-683a-438f-9c2f-c5edab34e024 61 fields · synced Jul 19, 2026
- FDA 510(k) K202560 1 fields · synced May 18, 2026