Identity
- Trade Name
- B3 SURGICAL BRA TG 04 bianco EUDAMED
- Device Name
- ekeep B3 SURGICAL BRA – Reggiseno post operatorio EUDAMED
- Model / Reference
- 5K2680D00AB04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054382243571 EUDAMED
- Basic UDI-DI
- 8054382245K2680SJ EUDAMED
- EMDN Code
- Y060307 THORACIC ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
B3 SURGICAL BRA TG 04 bianco by Dual Sanitaly S.p.A. SB — 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 | 8054382245K2680SJ | Class I | Active |
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Manufacturer
- Manufacturer
- Dual Sanitaly S.p.A. SB
- EUDAMED SRN
- IT-MF-000052906
Sources (1)
- EUDAMED bf7f5b3e-533c-441e-a581-f07cf66ce807 61 fields · synced Jul 15, 2026