Identity
- Trade Name
- Dye EUDAMED
- Device Name
- Dye EUDAMED
- Model / Reference
- HF91D EUDAMEDHF92N EUDAMEDHF93R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413836211 EUDAMED06944413836273 EUDAMED06944413836259 EUDAMED06944413836266 EUDAMED06944413836228 EUDAMED06944413836235 EUDAMED06944413836303 EUDAMED06944413836327 EUDAMED
- Basic UDI-DI
- 69444138HF91DL7 EUDAMED69444138HF92NLW EUDAMED69444138HF93RM9 EUDAMED
- EMDN Code
- W0103010199 REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER 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
Dye 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 | 69444138HF91DL7 | 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 (8)
- EUDAMED e5a23a42-31ab-4e29-84e9-92e1ea94db80 61 fields · synced Jul 19, 2026
- EUDAMED 97ceba4a-517a-4a8b-ac4d-4e7fea7fddf3 61 fields · synced May 17, 2026
- EUDAMED b683206d-7d51-467f-a665-81557efa7dfe 61 fields · synced May 17, 2026
- EUDAMED 8bde5906-dcba-422b-b3e9-6a698caaead1 61 fields · synced May 17, 2026
- EUDAMED a3525a48-9fa0-4310-8cab-64d192bb89c2 61 fields · synced May 18, 2026
- EUDAMED 5b78897e-20b3-4922-b27d-f2f1a17745f2 61 fields · synced May 19, 2026
- EUDAMED ddad579b-4bb8-45f1-8f53-190ccf285c68 61 fields · synced May 19, 2026
- EUDAMED 100f664e-9ce9-4635-81f5-9be1b1587e61 61 fields · synced May 19, 2026