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Sterilization Indicator Pouch
EUDAMEDClass I (EU MDR)
Ref HR-DBZDModel HR-DBZD, or customized
Identity
- Device Name
- Sterilization Indicator Pouch EUDAMED
- Model / Reference
- HR-DBZD, or customized EUDAMEDHR-DBZD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978547570475 EUDAMED
- Basic UDI-DI
- 697854757SIP2DBZDS3 EUDAMED
- EMDN Code
- S010199 STERILISATION POUCHES - 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 Indicator Pouch by Weihai Hengrui New Packaging Materials 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 | 697854757SIP2DBZDS3 | Class I | Active |
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Manufacturer
- Manufacturer
- Weihai Hengrui New Packaging Materials Co., Ltd.
- EUDAMED SRN
- CN-MF-000050315
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 90b0da97-b41f-40b0-9416-769c6023240e 61 fields · synced Jun 18, 2026