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Steam Sterilization Indicator Tape
EUDAMEDClass I (EU MDR)
Ref 8003.01Model 8003.01，8003.02，8003.03
Identity
- Device Name
- Steam Sterilization Indicator Tape EUDAMED
- Model / Reference
- 8003.01，8003.02，8003.03 EUDAMED8003.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978315815852 EUDAMED
- Basic UDI-DI
- 697831581Tape33 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - 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
Steam Sterilization Indicator Tape by Wuxi Weller Technology 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 | 697831581Tape33 | Class I | Active |
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Manufacturer
- Manufacturer
- Wuxi Weller Technology Co., LTD
- EUDAMED SRN
- CN-MF-000046706
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 7770dc9c-7391-4cdb-8b1d-074c559c31ab 61 fields · synced Jun 19, 2026