Identity
- Trade Name
- Catchem' EUDAMEDCatchem' Polyp Trap FDA UDI
- Generic Name
- Surgical suction system collection container, single-use FDA UDI
- Device Name
- Polyp Trap EUDAMEDSuction system canister, 4 chambers, fixed FDA UDI
- Model / Reference
- ET2213 EUDAMEDFDA UDI
- Description
- Suction system canister, 4 chambers, fixed FDA UDI
Identifiers
- Catalog Number
- ET2213 FDA UDI
- Primary DI / UDI-DI
- 00816207020389 EUDAMEDFDA UDI
- Basic UDI-DI
- 081620702polyptrapAK EUDAMED
- FDA Product Code
- KDQ FDA UDI
- EMDN Code
- G0399 DIGESTIVE ENDOSCOPY DEVICES - 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
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Catchem' by Endo-Therapeutics, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 081620702polyptrapAK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Endo-Therapeutics Inc.
- EUDAMED SRN
- US-MF-000002267
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED ec3272dc-81c7-47f4-addf-eab47e3876be 61 fields · synced Jun 19, 2026
- FDA UDI 4ef5e642-cee0-486f-91fa-baad0f501083 37 fields · synced May 29, 2026