3-piece Valve Kit
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- 3-piece Valve Kit EUDAMEDandorate® 3-piece Valve Kit FDA UDI
- Generic Name
- Endoscope channel support kit FDA UDI
- Device Name
- 3-piece Valve Kit EUDAMED
- Model / Reference
- 101004 EUDAMED101087 EUDAMEDGAR004 EUDAMEDFDA UDI101037 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897106958535 EUDAMED04897106957972 EUDAMED04897106953738 EUDAMEDFDA UDI04897106958542 EUDAMED
- Basic UDI-DI
- 489710695GAR004FA EUDAMED
- FDA Product Code
- OCX FDA UDIODC FDA UDI
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Endoscope channel support kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Tissue morcellation system handpiece, line-powered
3-piece Valve Kit by Ga Health Company Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 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
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 489710695GAR004FA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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 (8)
- EUDAMED 5f043f55-c9d1-46f1-9ae3-29ef8d31421e 61 fields · synced Jul 25, 2026
- EUDAMED 41dfdd8b-4499-4c1a-b084-9c5299f5ef2f 61 fields · synced May 17, 2026
- EUDAMED deec23a7-c04f-41d3-b4e0-4d9944bba9d3 61 fields · synced May 18, 2026
- EUDAMED b1ee8ac7-f3e6-4136-b4a4-5824935ed894 61 fields · synced May 19, 2026
- FDA UDI dcc9d6da-6050-4d0c-ac8f-d5b95cdba682 32 fields · synced May 29, 2026
- EUDAMED 128a4fa2-df70-4ecf-bb93-a768e863c052 61 fields · synced Jul 9, 2026
- EUDAMED 07fa7c44-7071-4452-a37b-ad519c766f78 61 fields · synced Jul 17, 2026
- EUDAMED 9c2d36c3-c2b7-4681-8133-0e33fbab2632 61 fields · synced Jul 25, 2026