Eu Mdd
Eu Md Class 2a
On The Market
🇰🇷 South Korea
VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 08809922810016
- Basic UDI-DI Code
- B-08809922810016
- Reference
- SPCS-IFU-SP03(CE)
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Speclipse, Inc.
Additional Description
- Spectra-Scope® Standalone is an objective spectroscopic system designed as a tool to aid medical professionals in the assessment of suspicious skin lesions for skin cancers. Spectra-Scope® Standalone is not meant to be used to make a definitive diagnosis or to replace the expert opinion of a medical professional. It is intended to provide information that may be useful to the medical professionals in the biopsy decision.
CND Nomenclature Codes
| Code | Description |
|---|---|
| V9099 | VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 289521-2019-CE-KOR-NA-PS | DNV Product Assurance AS | Expired |
Available In Countries
🇩🇪 Germany
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