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iReceptal™ Disposable Manifold
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref iRM400-01
Identity
- Trade Name
- iReceptal® Waste Fluid Management System Disposable Manifold EUDAMEDiReceptal™ Disposable Manifold FDA UDI
- Generic Name
- Suction system canister liner FDA UDI
- Device Name
- Waste fluid management system Rover EUDAMEDiReceptal™ Disposable Manifold FDA UDI
- Model / Reference
- iRM400-01 EUDAMED1 FDA UDI
- Description
- iReceptal™ Disposable Manifold FDA UDI
Identifiers
- Catalog Number
- iRM400-01 FDA UDI
- Primary DI / UDI-DI
- 00704411011234 EUDAMED40704411011232 FDA UDI
- Basic UDI-DI
- 0704411480Z9 EUDAMED
- Direct Marketing DI
- 00704411011234 EUDAMED
- FDA Product Code
- GCX FDA UDI
- EMDN Code
- A06030499 INTRA-OPERATION FLUID COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Suction system canister liner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 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: Suction system canister liner
iReceptal™ Disposable Manifold by Amsino International, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Suction system canister liner.
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- Bosma Enterprises — Bosma Enterprises · Class I
- Pergo — PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI · Class II
- DeRoyal — PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI · Class II
- Suction Liner — Shijiazhuang Yuanding Medical Device Co., LTD · Class II
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (2)
- FDA UDI 892da329-228a-4980-99f2-cf4e72ddda25 34 fields · synced Jul 14, 2026
- EUDAMED 161b549c-ceb7-4963-b224-c7228616990a 61 fields · synced Jul 14, 2026