Identity
- Trade Name
- CIDEZYME™ Enzymatic Detergent 5L EUDAMED
- Device Name
- CIDEZYME™ Enzymatic Detergent EUDAMED
- Model / Reference
- 2260 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10705037018161 EUDAMED
- Basic UDI-DI
- 0705037A100000000000010HD EUDAMED
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES 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
Category: Medical device disinfection agent
CIDEZYME™ Enzymatic Detergent 5L by Advanced Sterilization Products, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Manufacturer's product page: CIDEZYME™ XTRA Multi Enzymatic Detergent
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 | 0705037A100000000000010HD | Class I | Active |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products, Inc.
- EUDAMED SRN
- US-MF-000008427
- Authorised Representative
- ASP, The Netherlands B.V. NL-AR-000002057
Sources (1)
- EUDAMED 01efef1d-bc96-403d-ad2c-7041d5badd51 61 fields · synced Jul 17, 2026