Identity
- Trade Name
- EndoWipe Enzymatic Sponge EUDAMED
- Device Name
- EndoWipe Enzymatic Sponge EUDAMED
- Model / Reference
- 07-1020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00874485003609 EUDAMED
- Basic UDI-DI
- 087448500EndowipeLB EUDAMED
- EMDN Code
- Z12011380 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
EndoWipe Enzymatic Sponge by Cogentix Medical, 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 | 087448500EndowipeLB | Class I | Active |
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Manufacturer
- Manufacturer
- Cogentix Medical, Inc.
- EUDAMED SRN
- US-MF-000041661
- Authorised Representative
- Medical Measurement Systems B.V. NL-AR-000010438
Sources (1)
- EUDAMED 06e553a7-8139-4236-a0b6-cb2c48b34757 61 fields · synced Oct 6, 2026