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Intra oral Camera Sleeve/ sheath
EUDAMEDClass I (EU MDR)
Ref SD-6580Model SD-6580、SD-6594、SD-6615、SD-20831、SD-20963、SD-21013、SD-20855Ref SD-6594
Identity
- Trade Name
- Intra oral Camera Sleeve/ sheath EUDAMED
- Device Name
- Disposable Barrier Sleeves/Covers/Film EUDAMED
- Model / Reference
- SD-6580、SD-6594、SD-6615、SD-20831、SD-20963、SD-21013、SD-20855 EUDAMEDSD-6580 EUDAMEDSD-6594 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979999944203 EUDAMED06979999944210 EUDAMED
- Basic UDI-DI
- 697999994sleeve420B6 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
Intra oral Camera Sleeve/ sheath 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 | 697999994sleeve420B6 | 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 0524dbb4-cc89-4892-b14a-ae8082666f51 61 fields · synced Jul 8, 2026
- EUDAMED d7f31439-507c-49b2-99e2-35e058d67eb2 61 fields · synced May 16, 2026