Identity
- Trade Name
- Water Trap EUDAMEDNA FDA UDI
- Generic Name
- Breathing circuit condensate trap, single-use FDA UDI
- Device Name
- Water Trap EUDAMED
- Model / Reference
- 02.01.210520 EUDAMEDDewatering Cup(Single Patient Use, Adult/Pediatric 10ml) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413804999 EUDAMEDFDA UDI
- Basic UDI-DI
- 69444138WaterTrapZN EUDAMED
- FDA Product Code
- CCK FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Breathing circuit condensate trap, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1400 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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Electrical-only medical device connection cable, reusable
Water Trap by Edan Instruments, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69444138WaterTrapZN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED f18f45ba-cbdd-471d-8de0-2bd4689c5615 61 fields · synced Jul 10, 2026
- FDA UDI 77489ab9-d5d1-4ef2-bb95-427dedda9314 32 fields · synced May 30, 2026