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Surgical Gown
EUDAMEDClass I (EU MDR)
Ref L11001BModel Sterile Surgical gown，L ,1pc Sterile Surgical gown，S ,1pc Sterile Surgical gown，M ,1pc Sterile Surgical gown，XL ,1pc Sterile Surgical gown，XXL ,1pc, etc
Identity
- Device Name
- Surgical Gown EUDAMED
- Model / Reference
- Sterile Surgical gown，L ,1pc Sterile Surgical gown，S ,1pc Sterile Surgical gown，M ,1pc Sterile Surgical gown，XL ,1pc Sterile Surgical gown，XXL ,1pc, etc EUDAMEDL11001B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976594010111 EUDAMED
- Basic UDI-DI
- 697659401SG001LH EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Surgical Gown by Anhui Promise Healthcare 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 | 697659401SG001LH | Class I | Active |
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Manufacturer
- Manufacturer
- Anhui Promise Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000039766
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 4d0131cc-3253-4195-af4f-d87493027d8a 61 fields · synced Jun 19, 2026