Identity
- Trade Name
- Hood EUDAMEDZKSK FDA UDI
- Generic Name
- Surgical hood FDA UDI
- Device Name
- Hood EUDAMEDFDA UDI
- Model / Reference
- 18A-800 EUDAMEDFDA UDI
- Description
- Hood FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934415099882 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06934415099882 EUDAMED
- FDA Product Code
- FYF FDA UDI
- EMDN Code
- T0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
- GMDN Term
- Surgical hood FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Hood by Beijing ZKSK Technology Co., Ltd — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06934415099882 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Beijing ZKSK Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000010403
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 6932851a-4e01-487f-b758-7b5d7e7eb5be 61 fields · synced Oct 6, 2026
- FDA UDI b52f2ad8-c588-4266-ae89-8e1b84b3d3df 34 fields · synced May 30, 2026