Identity
- Trade Name
- Adjustable Comfort Bra Black Size 46 EUDAMED
- Device Name
- Compression Wear EUDAMED
- Model / Reference
- 216014600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00628999161467 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
Adjustable Comfort Bra Black Size 46 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 05879fcb-2fd6-45de-a289-3a00a4a5ee81 61 fields · synced Jul 22, 2026