Identity
- Trade Name
- Sterile Covers for Instruments EUDAMED
- Device Name
- Sterile Covers for Instruments EUDAMED
- Model / Reference
- Type 80 EUDAMED9001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973395870258 EUDAMED
- Basic UDI-DI
- 6973395879001GJ EUDAMED
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile Covers for Instruments by Principle & Will Biotech (Pinghu) 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 | 6973395879001GJ | Class I | Active |
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Manufacturer
- Manufacturer
- Principle & Will Biotech (Pinghu) Co., Ltd.
- EUDAMED SRN
- CN-MF-000037809
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 7a8851b0-f417-4c77-a09f-4a689c76262e 61 fields · synced Jun 18, 2026