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disposable bed sheet
EUDAMEDClass I (EU MDR)
Ref KTMDB01Model KTMDB01,KTMDB02.KTMDB03, KTMDB04 Or Customization
Identity
- Device Name
- disposable bed sheet EUDAMED
- Model / Reference
- KTMDB01,KTMDB02.KTMDB03, KTMDB04 Or Customization EUDAMEDKTMDB01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978914280044 EUDAMED
- Basic UDI-DI
- 697891428KTMDB001LG EUDAMED
- EMDN Code
- T030502 BED AND STRETCHER HYGIENIC COVERS 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
disposable bed sheet by Tianchang Kangtemei Protective Products 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 | 697891428KTMDB001LG | Class I | Active |
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Manufacturer
- Manufacturer
- Tianchang Kangtemei Protective Products Co., Ltd
- EUDAMED SRN
- CN-MF-000032474
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 437078e9-f950-4cf2-a595-153bfa3451f7 61 fields · synced Jun 19, 2026