Identity
- Device Name
- Cooler Box EUDAMED
- Model / Reference
- TDCB-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977793990082 EUDAMED
- Basic UDI-DI
- 697779399SZTD008RU EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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
Category: Device sterilization/disinfection container, reusable
Cooler Box by Suzhou Tedamed Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697779399SZTD008RU | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Tedamed Co., Ltd
- EUDAMED SRN
- CN-MF-000043696
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 5f8708c0-d5bc-4b07-b320-0a34dbfb1eab 61 fields · synced Aug 2, 2026