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Stermate
EUDAMEDClass IIb (EU MDR)
Ref STERMATEModel STERPACKModel STERPACK plus
Identity
- Model / Reference
- STERPACK EUDAMEDSTERMATE EUDAMEDSTERPACK plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800066500016 EUDAMED08800066500023 EUDAMED
- Basic UDI-DI
- B-08800066500016 EUDAMEDB-08800066500023 EUDAMED
- EMDN Code
- S900101 HYDROGEN PEROXIDE CARTRIDGES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Stermate by Plasmapp Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800066500016 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Plasmapp Co., Ltd
- EUDAMED SRN
- KR-MF-000012193
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED a04af931-7505-4c81-9200-a5e4266f612c 61 fields · synced Jul 16, 2026
- EUDAMED 672f856c-7323-45ca-b022-3093f6123aad 61 fields · synced May 17, 2026