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Pm
EUDAMEDFDA UDIClass I (EU MDR)
Ref SM-01-EModel SM-01-E SM-01-B SM-01-M SFMW04
Identity
- Trade Name
- PM EUDAMEDStandard Surgical Gown (AAMI Level 3) FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- Medical Face Masks EUDAMED
- Model / Reference
- SM-01-E SM-01-B SM-01-M SFMW04 EUDAMEDSM-01-E EUDAMEDPM5001SGN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973062320000 EUDAMEDFDA UDI
- Basic UDI-DI
- 697306232MASK03FG EUDAMED
- 510(k) Number
- K210143 FDA UDI
- FDA Product Code
- FYA FDA UDI
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
- GMDN Term
- Surgical gown, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Market of Registration
- Austria 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Pm by Foshan Nanhai Plus Medical Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697306232MASK03FG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Foshan Nanhai Plus Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000009816
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 1426b070-f1aa-4249-b832-348169f15ea6 61 fields · synced Jun 18, 2026
- FDA UDI bd4537fc-e508-4e5e-9ced-b6dcf28b4e97 33 fields · synced May 30, 2026