Identity
- Trade Name
- PelvicBinder – Adult Pink EUDAMED
- Device Name
- PelvicBinder EUDAMED
- Model / Reference
- PB EUDAMEDPK-4000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B911PK40000Q EUDAMED
- Basic UDI-DI
- ++B911PBA5 EUDAMED
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
PelvicBinder – Adult Pink by Pelvic Binder, 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 | ++B911PBA5 | Class I | Active |
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Manufacturer
- Manufacturer
- Pelvic Binder, Inc.
- EUDAMED SRN
- US-MF-000038428
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED f9e09fd3-dcf5-4fd0-a56d-9ba87ffd897e 61 fields · synced Jun 20, 2026