← Back to catalogue
Pm-375
EUDAMEDFDA UDIClass I (EU MDR)
Ref PM-375
by Jessop Precision Products, Inc (Trading as The Suremark Company)
Identity
- Trade Name
- PM-375 EUDAMEDPortalMark FDA UDI
- Generic Name
- Skin marking sticker FDA UDI
- Device Name
- PM SERIES EUDAMED
- Model / Reference
- PM-375 EUDAMEDPortalMark Isocenters for darker skin surfaces FDA UDI
Identifiers
- Primary DI / UDI-DI
- B971PM3751 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B971PortalMarkV4 EUDAMED
- FDA Product Code
- JAC FDA UDI
- EMDN Code
- V9004 SKIN MARKING DERMOGRAPHIC PENCILS AND PENS EUDAMED
- GMDN Term
- Skin marking sticker FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1640 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Pm-375 by Jessop Precision Products, Inc (Trading as The Suremark Company) — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | ++B971PortalMarkV4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- US-MF-000013348
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (2)
- EUDAMED 7052018e-22a3-44e3-a167-cacba93946a9 61 fields · synced Oct 6, 2026
- FDA UDI 5ab5a61a-9506-4984-8bdb-8e5d5ff5aff1 33 fields · synced May 30, 2026