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Sterile Surgical Gowns
EUDAMEDClass I (EU MDR)
Ref 101002Model S/M/L/XL/XXLRef 102004Ref 102005Ref 102003Ref 101005Ref 102002
Identity
- Trade Name
- Sterile Surgical Gowns EUDAMED
- Device Name
- Sterile Surgical Gowns EUDAMED
- Model / Reference
- S/M/L/XL/XXL EUDAMED101002 EUDAMED102004 EUDAMED102005 EUDAMED102003 EUDAMED101005 EUDAMED102002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973395870029 EUDAMED06973395870098 EUDAMED06973395870104 EUDAMED06973395870081 EUDAMED06973395870050 EUDAMED06973395870074 EUDAMED
- Basic UDI-DI
- 697339587101PL EUDAMED697339587102PN EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMEDT020402 REINFORCED SURGICAL GOWNS 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 Surgical Gowns 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 | 697339587101PL | 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 (6)
- EUDAMED f5a20983-484b-44a2-8acb-e1682b9096eb 61 fields · synced Jul 19, 2026
- EUDAMED 85538bb6-ac3c-4d73-9f43-d9721fd0c08a 61 fields · synced May 16, 2026
- EUDAMED 3195bc21-1138-4578-bd1b-71bc4ec15e5c 61 fields · synced May 16, 2026
- EUDAMED edd571ad-3389-46b2-a3f3-bd9b842de1bf 61 fields · synced May 16, 2026
- EUDAMED ebac04db-6ff0-4f48-83ef-6fdf7dd1fd86 61 fields · synced May 17, 2026
- EUDAMED 02099938-2698-4f1c-a7fc-c73eb112f6e1 61 fields · synced May 18, 2026