Identity
- Trade Name
- Dale Post-Surgical Bra, XXX-Large EUDAMEDDale Post Surgical Bra FDA UDI
- Generic Name
- Postsurgical brassiere, non-antimicrobial FDA UDI
- Device Name
- Post-Surgical Bra EUDAMEDDale Post Surgical Bra, XXX-Large, fits E-I, 54"-60", 1 per box. FDA UDI
- Model / Reference
- 706 EUDAMEDFDA UDI
- Description
- Dale Post Surgical Bra, XXX-Large, fits E-I, 54"-60", 1 per box. FDA UDI
Identifiers
- Catalog Number
- 706 FDA UDI
- Primary DI / UDI-DI
- 00817612020490 EUDAMEDFDA UDI
- Basic UDI-DI
- 0817612027066U 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Compression/pressure sock/stocking, reusable
Dale Post-Surgical Bra, XXX-Large 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
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0817612027066U | 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 d430b4b5-d7c3-4a71-b9af-0208bb22ad08 61 fields · synced Oct 6, 2026
- FDA UDI 2d84b1fe-98ba-49f0-b070-8f548ba4751a 35 fields · synced May 30, 2026