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Spectra-Scope Standalone
EUDAMEDClass IIa (EU MDR)
Ref SPCS-IFU-SP03(CE)Model SP03
Identity
- Device Name
- Spectra-Scope Standalone EUDAMED
- Model / Reference
- SP03 EUDAMEDSPCS-IFU-SP03(CE) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809922810016 EUDAMED
- Basic UDI-DI
- B-08809922810016 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Spectra-Scope Standalone by Speclipse, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809922810016 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Speclipse, Inc.
- EUDAMED SRN
- KR-MF-000026775
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (1)
- EUDAMED 18901fab-0965-437a-9690-10f89e6ea4e4 61 fields · synced Jul 25, 2026