Identity
- Trade Name
- Dale Medical EUDAMEDDale Post Surgical Bra FDA UDI
- Generic Name
- Postsurgical brassiere, non-antimicrobial FDA UDI
- Device Name
- Post-Surgical Bra Small EUDAMEDDale Post Surgical Bra, Small, fits A-C, 32"-34", 1 per box. FDA UDI
- Model / Reference
- 701 EUDAMEDFDA UDI
- Description
- Dale Post Surgical Bra, Small, fits A-C, 32"-34", 1 per box. FDA UDI
Identifiers
- Catalog Number
- 701 FDA UDI
- Primary DI / UDI-DI
- 00817612020964 EUDAMEDFDA UDI
- Basic UDI-DI
- 0817612027016J EUDAMED
- FDA Product Code
- HEF FDA UDI
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMED
- GMDN Term
- Postsurgical brassiere, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5160 FDA UDI
- Market of Registration
- Germany 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Compression/pressure sock/stocking, reusable
Dale Medical by Dale Medical Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0817612027016J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dale Medical Products, Inc.
- EUDAMED SRN
- US-MF-000019061
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 12d314c5-206d-474a-81c3-f281dca11bd7 61 fields · synced Jul 9, 2026
- FDA UDI b663509a-630a-413f-96ff-203f9232f74f 35 fields · synced May 29, 2026