Identity
- Trade Name
- Cleaner EUDAMED
- Device Name
- Cleaner EUDAMED
- Model / Reference
- HC600 EUDAMEDHC310 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413813922 EUDAMED06944413813953 EUDAMED06944413814097 EUDAMED06944413814066 EUDAMED
- Basic UDI-DI
- 69444138HC600HS EUDAMED69444138HC310HE EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Cleaner by Edan Instruments, Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69444138HC600HS | Class A | Active |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED 92d19215-008e-49ce-aab5-05e531bc11e1 61 fields · synced Aug 1, 2026
- EUDAMED 01270ac0-aa03-41fd-a91f-5be476b86207 61 fields · synced May 17, 2026
- EUDAMED 5f52d9e8-360d-4757-b327-f97ed131ce90 61 fields · synced May 18, 2026
- EUDAMED 91649915-6e9f-433e-aa53-c4c4cd041d12 61 fields · synced May 19, 2026