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sterilization packaging bag(roll)
EUDAMEDClass I (EU MDR)
Ref KTMSPB01Model KTMSPB01,KTMSPB02.KTMSPB03, KTMSPB04 Or Customization
Identity
- Device Name
- sterilization packaging bag(roll) EUDAMED
- Model / Reference
- KTMSPB01,KTMSPB02.KTMSPB03, KTMSPB04 Or Customization EUDAMEDKTMSPB01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978914280327 EUDAMED
- Basic UDI-DI
- 697891428KTMSPB001FR 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
sterilization packaging bag(roll) 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 | 697891428KTMSPB001FR | 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 50267cce-b14d-4abc-a363-9188dc54e1c3 61 fields · synced Jun 19, 2026