4-piece Valve Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- 4-piece Valve Kit EUDAMEDandorate® 4-piece Valve Kit FDA UDI
- Generic Name
- Endoscope channel support kit FDA UDI
- Device Name
- 4-piece Valve Kit EUDAMED
- Model / Reference
- 101046 EUDAMEDGAR092 EUDAMEDFDA UDI101066 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897106958559 EUDAMED04897106953776 EUDAMEDFDA UDI04897106957910 EUDAMED
- Basic UDI-DI
- 489710695GAR046FS EUDAMED
- FDA Product Code
- ODC 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 IIa 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
4-piece Valve Kit by Ga Health Company Limited — Class IIa — 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 | 489710695GAR046FS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 (6)
- EUDAMED 56ceacb4-8b2d-4894-a0c0-bff325902cb7 61 fields · synced Aug 1, 2026
- EUDAMED 9fcb514b-3762-4859-88ea-f509bd473ccc 61 fields · synced May 18, 2026
- EUDAMED edb96116-98ec-4fe8-91ce-12132cd8a8af 61 fields · synced May 18, 2026
- FDA UDI 931d1d69-5d06-4e86-88d3-0117a97f73bb 32 fields · synced May 30, 2026
- EUDAMED a4cdd310-75e3-4765-8c8e-53b801306918 61 fields · synced Jul 9, 2026
- EUDAMED 2e9d9bd8-411c-4228-8691-7ba72ef70e27 61 fields · synced Jul 12, 2026