Identity
- Trade Name
- AMSure® Cleansing Enema Set EUDAMEDFDA UDI
- Generic Name
- Gravity enema set FDA UDI
- Device Name
- Cleansing Enema Set EUDAMEDAMSure® Cleansing Enema Set CONTENTS: 1, One (1) each 1500 mL Enema Bag: -Pre-lubricated Tip - Tubing Clamp 2, Moisture Proof Drape 3, Enema Soap Packet FDA UDI
- Model / Reference
- AS330 EUDAMED1 FDA UDI
- Description
- AMSure® Cleansing Enema Set CONTENTS: 1, One (1) each 1500 mL Enema Bag: -Pre-lubricated Tip - Tubing Clamp 2, Moisture Proof Drape 3, Enema Soap Packet FDA UDI
Identifiers
- Catalog Number
- AS330 FDA UDI
- Primary DI / UDI-DI
- 10704411008378 EUDAMEDFDA UDI
- Basic UDI-DI
- 0704411804ZD EUDAMED
- FDA Product Code
- FCE FDA UDI
- EMDN Code
- G020199 GASTROINTESTINAL LAVAGE, TUBES AND SETS - OTHER EUDAMED
- GMDN Term
- Gravity enema set FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5210 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gravity enema set
AMSure® Cleansing Enema Set by Amsino International, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (2)
- FDA UDI d690f5d9-29e0-43c8-bab6-929694422247 34 fields · synced Jul 11, 2026
- EUDAMED 85d4c128-6ee1-4e4e-a4cd-15a66ea307fe 61 fields · synced Jul 11, 2026