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Surgical Drapes
EUDAMEDClass I (EU MDR)
Ref N/AModel Universal SizeRef S/M/LModel Is
Identity
- Device Name
- Surgical Drapes EUDAMED
- Model / Reference
- Universal Size EUDAMEDN/A EUDAMEDIs EUDAMEDS/M/L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975063464066 EUDAMED
- Basic UDI-DI
- B-06975063464066 EUDAMED697506346isdrapeKH EUDAMED
- EMDN Code
- T020102 SPECIALISTIC SURGERY DRAPES EUDAMEDT02010101 INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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 Drapes by Xiantao Fushi Protective Products Co., Ltd — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06975063464066 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06975063464066 | Class I | Active |
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Manufacturer
- Manufacturer
- Xiantao Fushi Protective Products Co., Ltd
- EUDAMED SRN
- CN-MF-000017275
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 0d4158be-e9e5-40e1-a0eb-112461a92b37 61 fields · synced Sep 17, 2026
- EUDAMED 2b0c7f96-bd93-44b6-a437-f99bd5e42dbc 61 fields · synced May 19, 2026