Polyp Trap with Two Removable Chambers
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Polyp Trap with Two Removable Chambers EUDAMEDandorate® ThomasTrap™ Polyp Trap with Two Removable Chambers FDA UDI
- Generic Name
- Surgical suction system collection container, single-use FDA UDI
- Device Name
- Polyp Trap EUDAMED
- Model / Reference
- GAR040 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897106953509 EUDAMEDFDA UDI
- Basic UDI-DI
- 489710695GAR014FD EUDAMED
- FDA Product Code
- CBC FDA UDI
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical suction system collection container, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Tissue morcellation system handpiece, line-powered
Polyp Trap with Two Removable Chambers 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
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- 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 | 489710695GAR014FD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 b3c23b28-8011-4499-9466-0c0122192237 61 fields · synced May 30, 2026
- FDA UDI 96f012a2-1ecc-4167-b8a1-a2b532815ab2 32 fields · synced May 25, 2026