Identity
- Trade Name
- CIDEX™ OPA Chemical Disinfectant Solution EUDAMED
- Device Name
- CIDEX™ OPA Chemical Disinfectant Solution EUDAMED
- Model / Reference
- 20391 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10705037000098 EUDAMED
- Basic UDI-DI
- 0705037A030000000000003L2 EUDAMED
- EMDN Code
- D010103 ORTHOPHTALALDEHYDE FOR THE DISINFECTION OF MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class IIb 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
CIDEX™ OPA Chemical Disinfectant Solution by Advanced Sterilization Products, Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: CIDEX™ OPA Solution
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 | 0705037A030000000000003L2 | Class IIb | 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 c0785eb8-9ce9-4059-92b1-7988f732f558 61 fields · synced Jul 30, 2026