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HEEL HUGGER™ with Magnets
EUDAMEDClass I (EU MDR)
Ref 50161 Model Small-Gel & Magnets
Identity
- Trade Name
- HEEL HUGGER™ with Magnets EUDAMED
- Device Name
- STEADY STEP® HEEL HUGGER™ with Magnets EUDAMED
- Model / Reference
- Small-Gel & Magnets EUDAMED50161 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00821615016190 EUDAMED
- Basic UDI-DI
- 082161STSTHHWMNZ EUDAMED
- EMDN Code
- M0304010101 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, LOW EXTENSIBILITY (<70%) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
HEEL HUGGER™ with Magnets by Brownmed, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 082161STSTHHWMNZ | Class I | Active |
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Manufacturer
- Manufacturer
- Brownmed, Inc.
- EUDAMED SRN
- US-MF-000008271
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 4ff98c6f-97cb-49a2-8a73-da7320a33c77 61 fields · synced Jul 12, 2026