Identity
- Device Name
- Postpartum Balloons EUDAMED
- Model / Reference
- BR-PPB-24F II EUDAMEDBR-PPB-24F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973245040480 EUDAMED06973245040473 EUDAMED
- Basic UDI-DI
- 697324504PPB0011J2 EUDAMED
- EMDN Code
- U100102 POSTPARTUM INTRAUTERINE CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Postpartum Balloons by Brun Medical Co., Ltd. — Class IIa — 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 | 697324504PPB0011J2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Brun Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000009738
- Authorised Representative
- Cnovate Medical B.V. NL-AR-000039205
Sources (2)
- EUDAMED 67912bea-8b40-42ac-b4e7-fc15fee36557 61 fields · synced Oct 6, 2026
- EUDAMED e82d6414-fe72-4e1c-a5cd-71568ada9327 61 fields · synced May 18, 2026