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Dental X-ray barrier envelopes
EUDAMEDClass I (EU MDR)
Ref E82Model E80,E81,E82,E90,E91,E92,BHT01,DG01,KS01,A6563,A6573,A6576,A6582-1,A6582-2,A6592,A6593,YKD02
Identity
- Trade Name
- Dental X-ray barrier envelopes EUDAMED
- Device Name
- Disposable dental Product Sleeve EUDAMED
- Model / Reference
- E80,E81,E82,E90,E91,E92,BHT01,DG01,KS01,A6563,A6573,A6576,A6582-1,A6582-2,A6592,A6593,YKD02 EUDAMEDE82 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978049073580 EUDAMED
- Basic UDI-DI
- 697804907E80RA EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Dental X-ray barrier envelopes by Anson Investment Development Co., 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 | 697804907E80RA | Class I | Active |
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Manufacturer
- Manufacturer
- Anson Investment Development Co., Ltd.
- EUDAMED SRN
- CN-MF-000049926
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 56b9d3e1-c3b0-449a-bc5b-620d1fb13d50 61 fields · synced Jun 18, 2026