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Eclipse PLUS
EUDAMEDClass IVD General (EU MDR)
Ref S35010Ref S5641012 S5641013Ref S5800401 S5800402Ref S5641008 S5641009
Identity
- Trade Name
- Eclipse PLUS EUDAMED
- Device Name
- Eclipse PLUS Multi-Purpose Analyzer EUDAMEDEclipse PLUS Creatinine Reagent Kit EUDAMEDEclipse PLUS Urine Control Solution EUDAMEDEclipse PLUS HbA1c Reagent Kit EUDAMED
- Model / Reference
- S35010 EUDAMEDS5641012 S5641013 EUDAMEDS5800401 S5800402 EUDAMEDS5641008 S5641009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47136487608B06P EUDAMEDD-47136487608BCRTYV EUDAMEDD-47136487608BURS3Q EUDAMEDD-47136487608BA1CTWR EUDAMED
- Basic UDI-DI
- B-47136487608B06P EUDAMEDB-47136487608BCRTYV EUDAMEDB-47136487608BURS3Q EUDAMEDB-47136487608BA1CTWR EUDAMED
- EMDN Code
- W0101060201,W010106020601,W0102160101,W0102160102,W020106019099 EUDAMEDW0101060201 URINE SINGLE TEST STRIPS (INCL. TABLETS) EUDAMEDW010106020601 URINE TESTING CONTROLS EUDAMEDW0102160102 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
Eclipse PLUS by Apex Biotechnology Corp. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-47136487608B06P | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
- EUDAMED SRN
- TW-MF-000019773
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED 05c9bfde-884a-4bf3-a998-f178b015bfcc 61 fields · synced Jul 23, 2026
- EUDAMED bda0d733-81ec-4117-8614-67d1c8eecbc1 61 fields · synced Jul 11, 2026
- EUDAMED 6f885205-8a81-4ae2-b9c6-60aecfa7d019 61 fields · synced Jul 20, 2026
- EUDAMED 46f79ee4-cf8e-4820-866e-34851ca6d7b6 61 fields · synced Jul 23, 2026