Identity
- Trade Name
- Suavel OP PRO Standard EUDAMED
- Device Name
- Disposable Surgical Gowns EUDAMED
- Model / Reference
- 5541 EUDAMED5544 EUDAMED5543 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932523090036 EUDAMED06932523090067 EUDAMED06932523090050 EUDAMED
- Basic UDI-DI
- 697170524Gowns12X2 EUDAMED
- EMDN Code
- T020401 STANDARD 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
Suavel OP PRO Standard by JiangSu MedPlus Non-Woven Manufacturer 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 | 697170524Gowns12X2 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Medplus Non-woven Manufacturer Co., Ltd.
- EUDAMED SRN
- CN-MF-000022548
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED e9c47463-d372-40ab-bce0-b7f28b4db77e 61 fields · synced Oct 6, 2026
- EUDAMED c5cff515-a5b2-4259-bd2b-e40512589a5b 61 fields · synced Jul 12, 2026
- EUDAMED 61e61fd3-c6f0-44c4-9fd4-ad759da9d16a 61 fields · synced Jul 22, 2026