Identity
- Trade Name
- SurgiCube EUDAMEDSurgiCube drape FDA UDI
- Generic Name
- Surgical dressing/drape kit, single-use FDA UDI
- Device Name
- SurgiCube EUDAMEDSurgical Drape for use with the SurgiCube air flow units are intended to be used as a sterile protective barrier between the outcoming filtered air of the air flow unit and the environmental air, protecting the clean air area from potential (non-) viable particles. FDA UDI
- Model / Reference
- SC200 EUDAMEDSCDR180 FDA UDI
- Description
- Surgical Drape for use with the SurgiCube air flow units are intended to be used as a sterile protective barrier between the outcoming filtered air of the air flow unit and the environmental air, protecting the clean air area from potential (non-) viable particles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720299748118 EUDAMED07350101640098 FDA UDI
- Basic UDI-DI
- 87202997481SCI95 EUDAMED
- Direct Marketing DI
- 08720299748118 EUDAMED
- FDA Product Code
- HMT FDA UDI
- EMDN Code
- V0899 MEDICAL SUPPORT EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Surgical dressing/drape kit, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Market of Registration
- Austria 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
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
Category: Surgical dressing/drape kit, single-use
SurgiCube drape by Toul Meditech AB — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Toul Meditech AB
Sources (2)
- FDA UDI 2270f729-40f8-479a-9ece-871c74a0181a 33 fields · synced Jul 14, 2026
- EUDAMED 4f481f33-5902-426d-bd7e-90ff86765279 61 fields · synced Jul 14, 2026