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X-ray sensor Sleeve/Cover
EUDAMEDClass I (EU MDR)
Ref SD-6581Model SD-6581、SD-6582-1、SD-6582-2、SD-6604、 SD-6609Ref SD-6582-1
Identity
- Trade Name
- X-ray sensor Sleeve/Cover EUDAMED
- Device Name
- Disposable Barrier Sleeves/Covers/Film EUDAMED
- Model / Reference
- SD-6581、SD-6582-1、SD-6582-2、SD-6604、 SD-6609 EUDAMEDSD-6581 EUDAMEDSD-6582-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979999944227 EUDAMED06979999944234 EUDAMED
- Basic UDI-DI
- 697999994sleeve422BA EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
X-ray sensor Sleeve/Cover by Snowdent Healthcare 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 | 697999994sleeve422BA | Class I | Active |
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Manufacturer
- Manufacturer
- Snowdent Healthcare Co., Ltd
- EUDAMED SRN
- CN-MF-000008775
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED adc1724d-7450-465c-b898-3836129263b7 61 fields · synced Sep 17, 2026
- EUDAMED d297c2e3-8331-43a7-93f5-d0075eb27a13 61 fields · synced May 18, 2026