Identity
- Trade Name
- Chewy EUDAMED
- Device Name
- Aligner Chewy EUDAMED
- Model / Reference
- Aligner chewy-White EUDAMEDSAWB/PL-AC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908018231046 EUDAMED
- Basic UDI-DI
- 89080182310853WPV EUDAMED
- EMDN Code
- L150704 ORTHODONTIC BAND PUSHERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Chewy by Sawbros Industries Pvt. Ltd. — 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 | 89080182310853WPV | Class I | Active |
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Manufacturer
- Manufacturer
- Sawbros Industries Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000016702
- Authorised Representative
- Meddevices Lifesciences B.V. NL-AR-000000594
Sources (1)
- EUDAMED ac2d0f0b-ca1c-4e5e-887f-81a26c689b28 61 fields · synced Jul 9, 2026