Identity
- Trade Name
- ROLLO 55X40X16E.HE(ETOILE) FDA UDI
- Generic Name
- Electrocardiographic recording paper FDA UDI
- Model / Reference
- 1005503 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08428763003236 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 55x40x16e.he(etoile) 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.
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- 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 |
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Manufacturer
- Manufacturer
- Ab Medica Group, S.a.
Sources (1)
- FDA UDI b802cdf3-2fbf-4705-b653-7cb9945479dd 33 fields · synced May 30, 2026