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Chemical Indicator Strip
EUDAMEDClass I (EU MDR)
Ref HHR-GZSK-2Model HHR-GZSK-1, HHR-GZSK-2, or customizedRef HR-EOK-2Model HR-EOK-1, HR-EOK-2, or customizedRef HR-ⅢZSK-2Model HR-ⅢZSK-1, HR-ⅢZSK-1, or customizedRef HR-ⅢZSK-1Ref HR-EOK-1Ref HHR-GZSK-1
Identity
- Device Name
- Chemical Indicator Strip EUDAMED
- Model / Reference
- HHR-GZSK-1, HHR-GZSK-2, or customized EUDAMEDHHR-GZSK-2 EUDAMEDHR-EOK-1, HR-EOK-2, or customized EUDAMEDHR-EOK-2 EUDAMEDHR-ⅢZSK-1, HR-ⅢZSK-1, or customized EUDAMEDHR-ⅢZSK-2 EUDAMEDHR-ⅢZSK-1 EUDAMEDHR-EOK-1 EUDAMEDHHR-GZSK-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978547570154 EUDAMED06978547570208 EUDAMED06978547570178 EUDAMED06978547570161 EUDAMED06978547570192 EUDAMED06978547570147 EUDAMED
- Basic UDI-DI
- 697854757CIS1GZSKMM EUDAMED697854757CIS4EOK7K EUDAMED697854757CIS2IIIZSKVB EUDAMED
- EMDN Code
- S0199 DEVICES FOR STERILISATION AND PACKAGING (EXCLUDING CAT. D - Z) - 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
Chemical Indicator Strip 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 | 697854757CIS1GZSKMM | 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 (6)
- EUDAMED dabac500-af8e-4da1-95d3-275bf6a93d0a 61 fields · synced Sep 30, 2026
- EUDAMED 054b8979-468a-4921-8db1-65233c1fabc3 61 fields · synced May 17, 2026
- EUDAMED cbeed050-bd69-4874-b219-0b1ba9de2c38 61 fields · synced May 17, 2026
- EUDAMED d4e7154f-9dfb-4bfa-9668-eafa8090cf19 61 fields · synced May 18, 2026
- EUDAMED 9f823a0f-c349-4e9a-8934-fe7cfb4fc28e 61 fields · synced May 18, 2026
- EUDAMED 426b5caf-0c66-47b6-85a3-93da704c3dd6 61 fields · synced May 18, 2026