Identity
- Trade Name
- ROLLO 57X10X12E.PRINTER.TRANSPORT (10 Y FDA UDI
- Generic Name
- Electrocardiographic recording paper FDA UDI
- Model / Reference
- 1005722 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08428763003458 FDA UDI
- FDA Product Code
- DSF FDA UDI
- GMDN Term
- Electrocardiographic recording paper FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.2810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic recording paper
Rollo 57x10x12e.printer.transport (10 Y by Ab Medica Group, S.a. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic recording paper.
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP · Class I
- GE Healthcare — GRAPHIC CONTROLS ACQUISITION CORP · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class I
- FUKUDA DENSHI — Fukuda Denshi Co., Ltd. · Class II
- ECG Recording Paper — Diagramma AG · Class I
- GE Healthcare — GRAPHIC CONTROLS ACQUISITION CORP · Class I
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP · Class I
- non branded — Cardinalhealth · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Manufacturer
- Ab Medica Group, S.a.
Sources (1)
- FDA UDI 22d2c1ca-cfaf-4221-85c0-b91a17050a65 33 fields · synced May 30, 2026