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Primostar 1
EUDAMEDClass A (EU MDR)
Ref 415501-0101-002Model Axioscope 5 / Axioscope 7/ Axiolab 5 / Primostar 3 / Primostar 1
Identity
- Trade Name
- Primostar 1 EUDAMED
- Device Name
- Upright microscope EUDAMED
- Model / Reference
- Axioscope 5 / Axioscope 7/ Axiolab 5 / Primostar 3 / Primostar 1 EUDAMED415501-0101-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06909262200361 EUDAMED
- Basic UDI-DI
- 6909262CNA003QD EUDAMED
- Direct Marketing DI
- 06909262200361 EUDAMED
- EMDN Code
- W0202050303 OPTICAL LABORATORY MICROSCOPES 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Primostar 1 by Carl Zeiss Suzhou Co., Ltd. — 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 | 6909262CNA003QD | Class A | Active |
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Manufacturer
- Manufacturer
- Carl Zeiss Suzhou Co., Ltd.
- EUDAMED SRN
- CN-MF-000017606
- Authorised Representative
- Carl Zeiss Microscopy GmbH DE-AR-000024425
Sources (1)
- EUDAMED 53456a51-5734-4818-be05-f9d5acad9666 61 fields · synced Jun 18, 2026