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Lyse
EUDAMEDClass A (EU MDR)
Ref HL600Ref HL620Ref HL90HRef HL610Ref HL92NRef HL310
Identity
- Trade Name
- Lyse EUDAMED
- Device Name
- Lyse EUDAMED
- Model / Reference
- HL600 EUDAMEDHL620 EUDAMEDHL90H EUDAMEDHL610 EUDAMEDHL92N EUDAMEDHL310 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413813915 EUDAMED06944413813908 EUDAMED06944413822405 EUDAMED06944413836082 EUDAMED06944413822399 EUDAMED06944413822382 EUDAMED06944413836150 EUDAMED06944413822368 EUDAMED06944413814073 EUDAMED06944413813472 EUDAMED06944413813489 EUDAMED06944413822436 EUDAMED06944413836136 EUDAMED
- Basic UDI-DI
- 69444138HL600KR EUDAMED69444138HL620KX EUDAMED69444138HL90HMN EUDAMED69444138HL610KU EUDAMED69444138HL92NN8 EUDAMED69444138HL310KD 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
Lyse 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 | 69444138HL600KR | 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 (13)
- EUDAMED 6a57fcd1-4a57-4228-ad83-7ded9771c384 61 fields · synced Jul 28, 2026
- EUDAMED 0e0bd9cb-9c54-4f74-a914-6124535229de 61 fields · synced May 11, 2026
- EUDAMED 8b70fe26-eb0d-4fea-823c-3aea9c6d84db 61 fields · synced May 16, 2026
- EUDAMED 0c02fba2-5803-4b58-b70b-2b5d857388d5 61 fields · synced May 17, 2026
- EUDAMED 22a9cb78-fb4c-4c94-be41-792eee6ce271 61 fields · synced May 17, 2026
- EUDAMED ecb82f66-48a5-4a19-971c-fd8df821752e 61 fields · synced May 17, 2026
- EUDAMED 1f5fcb35-e838-49ff-a78f-35c2c91d345e 61 fields · synced May 18, 2026
- EUDAMED 3b9658e9-a380-4555-b792-7d81cc7b503b 61 fields · synced May 19, 2026
- EUDAMED 092a237e-2992-49eb-a094-57e4f8f0f166 61 fields · synced May 19, 2026
- EUDAMED f0daabb4-9ce1-4041-b9a3-b333b1ae2d66 61 fields · synced May 19, 2026
- EUDAMED ecc6ed9d-188f-44df-91b0-3ba80a03d71d 61 fields · synced May 19, 2026
- EUDAMED d449d079-5c11-4f28-98b1-0f35fd96d39f 61 fields · synced May 19, 2026
- EUDAMED e722714e-31a1-4e6b-820b-3094f1a9a2cf 61 fields · synced May 19, 2026