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Self‑Sealing Sterilization Pouch
EUDAMEDClass I (EU MDR)
Ref 8001.01 Model 8001.01, 8001.02, 8001.03, 8001.04, 8001.05, 8001.06, 8002.01, 8002.02, 8002.03, 8002.04, 8002.05, 8002.06, 8002.07, 8002.08, 8002.09, 8002.10
Identity
- Device Name
- Self‑Sealing Sterilization Pouch EUDAMED
- Model / Reference
- 8001.01, 8001.02, 8001.03, 8001.04, 8001.05, 8001.06, 8002.01, 8002.02, 8002.03, 8002.04, 8002.05, 8002.06, 8002.07, 8002.08, 8002.09, 8002.10 EUDAMED8001.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978315815692 EUDAMED
- Basic UDI-DI
- 697831581PouchBK 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
Self‑Sealing Sterilization Pouch 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 | 697831581PouchBK | 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 f97d0014-bbc0-446d-9872-cea6cbeff50d 61 fields · synced Jun 19, 2026