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Cheek Retractor Set of 2 pcs (Flexible Plastcc
EUDAMEDClass I (EU MDR)
Ref PI011
Identity
- Trade Name
- Cheek Retractor Set of 2 pcs (Flexible Plastcc EUDAMED
- Device Name
- Cheek Retractor Set of 2 pcs (Flexible Plastcc EUDAMED
- Model / Reference
- PI011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G796PI0110 EUDAMED
- Basic UDI-DI
- ++G796PI01157 EUDAMED
- EMDN Code
- L150201 DENTAL RETRACTORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
Yes
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
Cheek Retractor Set of 2 pcs (Flexible Plastcc by Promed Instruments — 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 | ++G796PI01157 | Class I | Active |
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Manufacturer
- Manufacturer
- Promed Instruments
- EUDAMED SRN
- PK-MF-000049405
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (1)
- EUDAMED 221fb4d3-1635-4a68-9d96-3cbd65f42610 61 fields · synced Jun 19, 2026