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Primostar 3
EUDAMEDClass A (EU MDR)
Ref 415501-0051-000Model Axioscope 5 / Axioscope 7/ Axiolab 5 / Primostar 3 / Primostar 1 Ref 415501-0001-000Ref 415501-0061-000Ref 415501-0091-000Ref 415501-0031-001Ref 415501-0231-000Ref 415501-0011-000Ref 415501-0021-001
Identity
- Trade Name
- Primostar 3 EUDAMED
- Device Name
- Upright microscope EUDAMED
- Model / Reference
- Axioscope 5 / Axioscope 7/ Axiolab 5 / Primostar 3 / Primostar 1 EUDAMED415501-0051-000 EUDAMED415501-0001-000 EUDAMED415501-0061-000 EUDAMED415501-0091-000 EUDAMED415501-0031-001 EUDAMED415501-0231-000 EUDAMED415501-0011-000 EUDAMED415501-0021-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06909262200224 EUDAMED06909262200187 EUDAMED06909262200217 EUDAMED06909262200347 EUDAMED06909262200309 EUDAMED06909262200354 EUDAMED06909262200200 EUDAMED06909262200279 EUDAMED
- Basic UDI-DI
- 6909262CNA003QD EUDAMED
- Direct Marketing DI
- 06909262200224 EUDAMED06909262200187 EUDAMED06909262200217 EUDAMED06909262200347 EUDAMED06909262200309 EUDAMED06909262200354 EUDAMED06909262200200 EUDAMED06909262200279 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 3 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 (8)
- EUDAMED b3f1aa92-6a79-4c2a-8d47-b2e5fdff5635 61 fields · synced Sep 18, 2026
- EUDAMED 0192d9cd-8e49-4c80-88da-6d4f24d247fd 61 fields · synced May 16, 2026
- EUDAMED c04bc3e9-2728-47d6-ad8e-dd9857ff058d 61 fields · synced May 16, 2026
- EUDAMED cfbc958d-0269-47f7-b677-9dd7eaca94a0 61 fields · synced May 17, 2026
- EUDAMED 24858093-9dd5-4124-825f-35634e2e4ea7 61 fields · synced May 17, 2026
- EUDAMED aa5b0afa-e2cb-4ee9-9946-fcaf3934f4c2 61 fields · synced May 18, 2026
- EUDAMED c7eff87f-a6a8-4e22-a0ac-fabc17efdf8e 61 fields · synced May 19, 2026
- EUDAMED 5df2422d-0e86-478f-a599-73fe9685a92d 61 fields · synced May 19, 2026