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Nice Stretch
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 53101 Model Large/X-Large Ref 26921Model Adult Leg
Identity
- Trade Name
- PF Sleeve EUDAMEDStretch EUDAMEDNice Stretch FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- NICE STRETCH® PF Sleeve EUDAMEDSEAL-TIGHT® Stretch EUDAMEDPlantar Fasciitis Sleeve FDA UDI
- Model / Reference
- 53101 EUDAMEDFDA UDILarge/X-Large EUDAMEDAdult Leg EUDAMED26921 EUDAMED
- Description
- Plantar Fasciitis Sleeve FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06498335310170 EUDAMED00082161269212 EUDAMED00649833531017 FDA UDI
- Basic UDI-DI
- 081261NSPFSLGXLRE EUDAMED082161STSTALAR EUDAMED
- FDA Product Code
- ITW FDA UDI
- EMDN Code
- M0304010101 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, LOW EXTENSIBILITY (<70%) EUDAMEDM03030299 PROTECTION SYSTEMS - OTHER EUDAMED
- GMDN Term
- Ankle/foot orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ankle/foot orthosis
Nice Stretch by Brownmed, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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
- Brownmed, Inc.
Sources (3)
- FDA UDI a3d237e4-804f-438c-9ae3-8207702766c9 33 fields · synced Jul 9, 2026
- EUDAMED 6069b8d8-13fd-46d8-9519-307c710777c9 61 fields · synced Jun 19, 2026
- EUDAMED 5dc3a31d-8534-44d3-9f65-4ecb373202f9 61 fields · synced Jul 8, 2026