Identity
- Trade Name
- Open Bust Bodysuit Beige X-Large EUDAMED
- Device Name
- Compression Wear EUDAMED
- Model / Reference
- 77102XL00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00628999331884 EUDAMED
- Basic UDI-DI
- 6289992345789FY EUDAMED
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Open Bust Bodysuit Beige X-Large by ClearPoint Medical Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6289992345789FY | Class I | Active |
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Manufacturer
- Manufacturer
- ClearPoint Medical Inc.
- EUDAMED SRN
- CA-MF-000037311
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 259afd52-3d1d-4eb2-8656-056390fd9e69 61 fields · synced Aug 1, 2026