Identity
- Trade Name
- ZipperBelt EUDAMED
- Device Name
- ZipperBelt EUDAMED
- Model / Reference
- ZB EUDAMEDB911ZB EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B911ZPR0010M EUDAMED
- Basic UDI-DI
- ++B911ZBB3 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
ZipperBelt 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 | ++B911ZBB3 | 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 10cee83a-bc7b-4139-aa0a-939cddbd7db3 61 fields · synced Jul 22, 2026