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Dome Bag
EUDAMEDClass I (EU MDR)
Ref E5315Ref E5338Ref E5319Ref E5314NRef AM5314Ref E5305Ref E5327NRef DEF767Ref E5309NRef E5310Ref E5308Ref E5484Ref E5328Ref E5305NRef EDB40NRef E5312Ref DEF764Ref EDB18NRef E5487Ref E5307NRef E5329Ref E5488Ref DEF770Ref W5309NRef E5303Ref E5331Ref E5337NRef E5313Ref E5324Ref 105172080Ref EDB22NRef E5321Ref E7000Ref E5307Ref W5307NRef EDB30NRef E5313NRef E5310NRef E5314Ref E5308NRef E5311NRef W5311NRef E5332Ref E5486Ref E5301
Identity
- Trade Name
- Dome Bag EUDAMED
- Device Name
- Dome Bag EUDAMED
- Model / Reference
- E5315 EUDAMEDE5338 EUDAMEDE5319 EUDAMEDE5314N EUDAMEDAM5314 EUDAMEDE5305 EUDAMEDE5327N EUDAMEDDEF767 EUDAMEDE5309N EUDAMEDE5310 EUDAMEDE5308 EUDAMEDE5484 EUDAMEDE5328 EUDAMEDE5305N EUDAMEDEDB40N EUDAMEDE5312 EUDAMEDDEF764 EUDAMEDEDB18N EUDAMEDE5487 EUDAMEDE5307N EUDAMEDE5329 EUDAMEDE5488 EUDAMEDDEF770 EUDAMEDW5309N EUDAMEDE5303 EUDAMEDE5331 EUDAMEDE5337N EUDAMEDE5313 EUDAMEDE5324 EUDAMED105172080 EUDAMEDEDB22N EUDAMEDE5321 EUDAMEDE7000 EUDAMEDE5307 EUDAMEDW5307N EUDAMEDEDB30N EUDAMEDE5313N EUDAMEDE5310N EUDAMEDE5314 EUDAMEDE5308N EUDAMEDE5311N EUDAMEDW5311N EUDAMEDE5332 EUDAMEDE5486 EUDAMEDE5301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975085702245 EUDAMED06975085701415 EUDAMED06975085701514 EUDAMED06975085702863 EUDAMED06975424198180 EUDAMED06975085702337 EUDAMED06975085702894 EUDAMED06975424191839 EUDAMED06975085702740 EUDAMED06975085702283 EUDAMED06975085702306 EUDAMED06975085701361 EUDAMED06975085701460 EUDAMED06975085702634 EUDAMED06975085703198 EUDAMED06975085702269 EUDAMED06975424191822 EUDAMED06975085703082 EUDAMED06975085701330 EUDAMED06975085702672 EUDAMED06975085701453 EUDAMED06975085701323 EUDAMED06975424191846 EUDAMED06975085706083 EUDAMED06975085702344 EUDAMED06975085701446 EUDAMED06975085702948 EUDAMED06975085702252 EUDAMED06975085701484 EUDAMED06975424193475 EUDAMED06975085703112 EUDAMED06975085701507 EUDAMED06975085701309 EUDAMED06975085702313 EUDAMED06975085705895 EUDAMED06975085703174 EUDAMED06975085702849 EUDAMED06975085702771 EUDAMED06975085701538 EUDAMED06975085708827 EUDAMED06975085702825 EUDAMED06975085706885 EUDAMED06975085702207 EUDAMED06975085701347 EUDAMED06975085702351 EUDAMED
- Basic UDI-DI
- 697508570EC01HZ EUDAMED
- EMDN Code
- T030101 COVER CAPS, INSTRUMENTS AND EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
Category: Vascular booties
Dome Bag by Exact Medical Manufacturing, Inc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697508570EC01HZ | Class I | Active |
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Manufacturer
- Manufacturer
- Exact Medical Manufacturing, Inc
- EUDAMED SRN
- CN-MF-000001406
- Authorised Representative
- Exact Medical Manufacturing B.V. NL-AR-000000452
Sources (45)
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