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Barrier Envelopes for phosphor storage plates
EUDAMEDClass I (EU MDR)
Ref SD-5001Model SD-5001、Size #0、#1、#2、#3、#4
Identity
- Trade Name
- Barrier Envelopes for phosphor storage plates EUDAMED
- Device Name
- Disposable Barrier Sleeves/Covers/Film EUDAMED
- Model / Reference
- SD-5001、Size #0、#1、#2、#3、#4 EUDAMEDSD-5001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979999944364 EUDAMED
- Basic UDI-DI
- 697999994sleeve436BM 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
Barrier Envelopes for phosphor storage plates 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 | 697999994sleeve436BM | 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 (1)
- EUDAMED c42c9fa8-2c32-4642-a177-530b54d7e23d 61 fields · synced Jun 18, 2026