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iReceptal® Surgical Smoke Evacuate ULPA Filter
EUDAMEDClass I (EU MDR)
Ref iRF500
Identity
- Trade Name
- iReceptal® Surgical Smoke Evacuate ULPA Filter EUDAMED
- Device Name
- Surgical Smoke Evacuate ULPA Filter EUDAMED
- Model / Reference
- iRF500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00704411018219 EUDAMED
- Basic UDI-DI
- 0704411498ZU EUDAMED
- Direct Marketing DI
- 00704411018219 EUDAMED
- EMDN Code
- A06030499 INTRA-OPERATION FLUID COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
iReceptal® Surgical Smoke Evacuate ULPA Filter by Amsino International, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0704411498ZU | Class I | Active |
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Manufacturer
- Manufacturer
- Amsino International Inc.
- EUDAMED SRN
- US-MF-000007234
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 1615edaf-cea5-4688-882e-620aa85fff68 61 fields · synced Jul 14, 2026