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Barrier Film Dispenser
EUDAMEDClass I (EU MDR)
Ref 1A6539-HModel 1A6539-H 1A6539
Identity
- Trade Name
- Barrier Film Dispenser EUDAMED
- Device Name
- Barrier Film Dispenser EUDAMED
- Model / Reference
- 1A6539-H 1A6539 EUDAMED1A6539-H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977493108299 EUDAMED
- Basic UDI-DI
- 697749310010014V7 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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 Film Dispenser by Shanghai Dochem Industries 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 | 697749310010014V7 | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Dochem Industries Co., Ltd.
- EUDAMED SRN
- CN-MF-000014350
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED bf103ed4-c871-4295-81ce-c17b8c2b74f4 61 fields · synced Jun 19, 2026