Identity
- Trade Name
- CRAMER ECO-FLEX TAPE, 3"X6YDS, BLACK, 16/CS EUDAMEDCramer FDA UDI
- Generic Name
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
- Device Name
- CRAMER TAPE EUDAMEDEco-Flex Stretch Tape, Black 3” x 6yd Case of 16 FDA UDI
- Model / Reference
- 285115 EUDAMEDFDA UDIATHLETIC TAPE EUDAMED
- Description
- Eco-Flex Stretch Tape, Black 3” x 6yd Case of 16 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00311960751629 EUDAMEDFDA UDI
- Basic UDI-DI
- 03119600000000000000002GJ EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMED
- GMDN Term
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 15 Yard FDA UDIWidth — 2 Inch FDA UDI
Category: Dressing-fixation skin adhesive tape, non-silicone
Cramer by Hygenic Corporation, The — Class I — 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hygenic Corporation, The
Sources (2)
- FDA UDI 0ba49507-3eca-4fb3-9e62-730f645641b8 34 fields · synced Jul 14, 2026
- EUDAMED 5cf97985-1a3c-4882-adf6-fdfa24a63dfd 61 fields · synced Jul 14, 2026